A Phase 3 interventional study of Everolimus and Tacrolimus in Pediatric Heart Transplantation, Immunosuppression and Chronic Kidney Diseases, sponsored by Boston Children's Hospital. Completed at 25 sites in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Boston Children's Hospital · Phase 3, Interventional, and Treatment
Among 987 studies in Renal Insufficiency, Chronic with a site in United States — 172 open to participants now, 219 under way, 24 of them phase 3. Renal Insufficiency, Chronic · United States.
Among the 987 studies in Renal Insufficiency, Chronic with a site in United States, this one is the 215th largest by enrollment of the 818 interventional ones, is one of 46 that started in 2018, is one of 146 in phase 3, and was the 526th registered.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 211 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →172 of the 987 studies in Renal Insufficiency, Chronic with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 435 Renal Insufficiency, Chronic studies recruiting now, 245 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.
This study: Up to 21 Years · all sexes · no healthy volunteers.
The full table on the hub →987 studies; the count open now beside each. This study's row is marked.
First in 1988; this study’s year is marked. 46 started in 2018.
Median enrollment 71 across the 818 interventional studies, 125 across the 165 observational. Of the 695 that completed or were terminated, 344 (49%) have results posted.
371 of 987 have an industry lead sponsor. The 10 most frequent:
Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Boston Children's Hospital has 1 study filed under Renal Insufficiency, Chronic — fewer than ten, so there is no comparison to draw.
73 of the studies in Renal Insufficiency, Chronic with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03565913Phase 3University of Texas Southwestern Medical CenterPotential Therapeutic Role of Effervescent Calcium-Magnesium Citrate in Chronic Kidney Disease Stage V | 2026-12-01 |
| NCT06531824Phase 3Boehringer IngelheimEASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) | 2026-12-31 |
| NCT05196035Phase 3BayerA Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria | 2027-04-10 |
| NCT07107945Phase 3Boehringer IngelheimA Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids) | 2027-04-16 |
| NCT05852938Phase 3Novartis PharmaceuticalsA Study of Zigakibart in Adults With IgA Nephropathy | 2027-08-10 |
Among the 987 studies in Renal Insufficiency, Chronic with a site in United States, from their registry updates:
The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years. Half of the participants will receive everolimus and low-dose tacrolimus and the other half will receive tacrolimus and mycophenolate mofetil. The trial will determine which treatment is better at reducing the cumulative risk of coronary artery vasculopathy, chronic kidney disease and biopsy proven-acute cellular rejection without an increase in graft loss due to all causes (e.g. infection, PTLD, antibody mediated rejection).
Median survival after pediatric heart transplantation (HT) is 15 years in the current era. This means that a substantial fraction of patients transplanted during childhood fail to survive to adulthood, or require heart re-transplantation, because of complications related to heart transplant. These complications include heart transplant rejection, infection, coronary artery disease, post-transplant lymphoproliferative disorder (PTLD; a form of lymphoma seen in transplant recipients), and kidney failure. Most complications stem not from the heart transplant itself, but from the drugs commonly used to suppress the immune system in order to prevent rejection. In the US, tacrolimus (TAC) and mycophenolate mofetil (MMF), have emerged over the past decade as the standard of care for pediatric heart transplant immunosuppression. While pediatric survival has improved significantly in the era of TAC and MMF, post-HT complications remain a major problem that limits median survival to 15 years. Recently, everolimus (EVL) has emerged as a potential alternative immunosuppressant that may prevent rejection, coronary artery disease and kidney failure more effectively than TAC/MMF when administered in combination with low-dose tacrolimus (LDTAC). Preliminary studies suggest that EVL, and its first-generation analog sirolimus, are well tolerated in children after HT, regardless of whether it is started in response to coronary artery disease, in response to chronic kidney disease, or empirically 4-6 months after transplant in an effort to prevent the development of these complications1. However, studies are generally limited to single-center experiences using historical controls and have inadequate statistical power to demonstrate treatment differences. This will be the first multicenter randomized clinical trial of maintenance immunosuppression in pediatric heart transplantation to systematically evaluate the safety and efficacy of EVL with LDTAC vs. TAC/MMF to prevent long-term complications which lead to death/graft loss. The major adverse transplant event (MATE) score will serve as the primary endpoint to power the trial. Because no Food \& Drug Administration (FDA)-approved immunosuppressants currently exist for children after heart transplant (all prescriptions are off-label) and market incentives to support a trial are limited, the investigators have funded the trial through a Fiscal Year 2016 Peer Reviewed Medical Research Program Clinical Trial Award sponsored by the Department of Defense office of the Congressionally Directed Medical Research Programs. It is worth noting that in contrast to adults, children have a substantially longer potential life expectancy if post-transplant complications can be minimized, making the prevention of late complications an urgent priority for the pediatric heart transplant community.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Everolimus approximately 0.6 mg/m2/dose taken by mouth every 12 hours for 30 months. Everolimus dose will be adjusted to achieve a trough concentration of 3-8 ng/ml. Tacrolimus 0.0125 mg/kg/dose by mouth every 12 hours for 30 months. (Tacrolimus dose will be adjusted to achieve a trough concentration of 3-5 ng/ml until subjects are 1 year post-heart transplant. After 1 year post-heart transplant the tacrolimus dose will be adjusted to achieve a trough concentration of 2.5-4.5 ng/mL.)
Drug: Everolimus · Drug: Tacrolimus
Tacrolimus 0.05 mg/kg/dose by mouth every 12 hours for 30 months. (Tacrolimus dose will be adjusted to achieve a trough concentration of 7-10 ng/ml until subjects are 1 year post-heart transplant. After 1 year post-heart transplant the tacrolimus dose will be adjusted to achieve a trough concentration of 5-8 ng/mL.) Mycophenolate mofetil 600 mg/m2/dose by mouth every 12 hours for 30 months.
Drug: Tacrolimus · Drug: Mycophenolate Mofetil
Everolimus tablet
Also known as: Zortress
Tacrolimus capsule or liquid suspension
Also known as: Prograf
Mycophenolate Mofetil capsule or liquid suspension
Also known as: Cellcept
EFFICACY: MATE-3 Score
MATE-3 is a validated score ranging from 0 to 12. The score adds together each subscore so that it represents the cumulative burden of three major adverse transplant events: Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). Complete details of the score can be found in the study protocol. A higher score represents a worse outcome.
Time frame: 30 months post-randomization
SAFETY: MATE-6 Score
MATE-6 is a validated score ranging from 0 to 24. The score adds together each subscore so that it represents the cumulative burden of all six major adverse transplant events: Coronary Artery Vasculopathy (CAV), Chronic Kidney Disease (CKD), Biopsy-proven Acute Cellular Rejection (ACR), pathologic diagnosis of Antibody-Mediated Rejection (AMR), Infection, and Post-Transplant Lymphoproliferative Disorder (PTLD). Complete details of the score can be found in the study protocol. A higher score represents a worse outcome.
Time frame: 30 months post-randomization
Efficacy: Overall Patient Survival
Number of participants who experienced death from any cause
Time frame: Up to 30 months post-randomization
Efficacy: Overall Allograft Survival
Number of participants who experienced death or heart re-transplantation
Time frame: Up to 30 months post-randomization
Efficacy: Change in Kidney Function
Change in estimated glomerular filtration rate (eGFR) using the modified Schwartz equation. A positive number indicates improved kidney function, a negative number indicates worsened kidney function.
Time frame: 0 to 6 months, 0 to 12 months, 0 to 30 months post-randomization
Efficacy: Freedom From CKD Event
Number of participants who are "free from" (have NOT experienced) a chronic kidney disease MATE. A chronic kidney disease MATE was defined as an eGFR \< 60 ml/min/1.73 m\^2 during follow-up or worsening by at least one MATE score if \< 60 ml/min/1.73 m\^2 at baseline. A higher number of participants on this measure indicates a better outcome.
Time frame: From enrollment to 30 months after enrollment
Efficacy: Freedom From CAV Event
Number of participants who are "free from" (have NOT experienced) cardiac allograft vasculopathy (CAV) during follow up as graded by the angiography core laboratory. A higher number of participants on this measure indicates a better outcome.
Time frame: From enrollment to 30 months after enrollment
Efficacy: Freedom From BP-ACR Event
Number of participants who are "free from" (have NOT experienced) biopsy-proven Acute Cellular Rejection (ACR) MATE event during follow-up. A higher number of participants on this measure indicates a better outcome.
Time frame: From enrollment to 30 months after enrollment
Efficacy: Freedom From Composite Failure
Number of participants who are "free from" (have NOT experienced) the composite of death, graft loss, 2R/3R acute cellular rejection or rejection with hemodynamic compromise. A higher number of participants on this measure indicates a better outcome.
Time frame: From enrollment to 30 months after enrollment
Efficacy: EuroQOL EQ-5D Y (Youth Version)
The EuroQOL EQ-5D Y uses a visual-analog scale and asks the participant to mark an X on the line to show how good or bad your is health TODAY. The scale ranges from 0 to 100.
Time frame: 30 months post-randomization
Safety: Freedom From AMR
Number of participants who are "free from" (have NOT experienced) a pathologic diagnosis of Antibody-Mediated Rejection (AMR) MATE Event. A higher number of participants on this measure indicates a better outcome.
Time frame: From enrollment to 30 months after enrollment
Safety: Freedom From Infection
Number of participants who are "free from" (have NOT experienced) a serious infection MATE during follow-up. A higher number of participants on this measure indicates a better outcome.
Time frame: From enrollment to 30 months after enrollment
Safety: Freedom From PTLD
Number of participants who are "free from" (have NOT experienced) a Post-Transplant Lymphoproliferative Disorder (PTLD) MATE event during follow-up. A higher number of participants on this measure indicates a better outcome.
Time frame: From enrollment to 30 months after enrollment
Safety: Number of Participants Experiencing Adverse Events
Adverse events reported throughout the study. Adverse events are classified by CTCAE classification. Serious adverse events include CTCAE classes 3, 4, and 5.
Time frame: From enrollment to 30 months after enrollment
Safety: Freedom From Major Transplant Events (Composite)
Number of participants who are "free from" (have NOT experienced) any MATE event, this includes chronic kidney disease, cardiac allograft vasculopathy, acute cellular rejection, antibody mediated rejection, serious infection, and post-transplant lymphoproliferative disease. A higher number of participants on this measure indicates a better outcome.
Time frame: From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity CKD Event
Number of participants who are "free from" (have NOT experienced) a chronic kidney disease MATE of Grade 2 or greater (eGFR \<45 ml/min/1.73 m\^2 or on dialysis) or death due to chronic kidney disease. A higher number of participants on this measure indicates a better outcome.
Time frame: From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity CAV Event
Number of participants who are "free from" (have NOT experienced) a cardiac allograft vasculopathy MATE of Grade 2 or greater. Grade 2 or greater is the same as having International Society of Heart and Lung Transplantation cardiac allograft vasculopathy Grade 2 or 3 or death due to cardiac allograft vasculopathy. A higher number of participants on this measure indicates a better outcome.
Time frame: From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity ACR Event
Number of participants who are "free from" (have NOT experienced) an acute cellular rejection MATE of Grade 2 or greater. Grade 2 or greater is the equivalent of treated rejection with an assigned International Society of Heart \& Lung Transplantation acute cellular rejection grade 2 or grade 3 or rejection with hemodynamic compromise (decreased ejection fraction, need for IV medicine to support heart, need for mechanical circulatory support) or death due to acute cellular rejection. A higher number of participants on this measure indicates a better outcome.
Time frame: From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity AMR Event
Number of participants who are "free from" (have NOT experienced) an antibody mediated rejection MATE of Grade 2 or greater. Grade 2 or greater is the equivalent of treated rejection with an assigned International Society of Heart \& Lung Transplantation antibody mediated rejection grade 2 or grade 3 or antibody mediated rejection with hemodynamic compromise (decreased ejection fraction, need for IV medicine to support heart, need for mechanical circulatory support) or death due to antibody mediated rejection. A higher number of participants on this measure indicates a better outcome.
Time frame: From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity Infection Event
Number of participants who are "free from" (have NOT experienced) a serious infection MATE of Grade 2 or greater. Grade 2 infections require treatment with intravenous antibiotics or antivirals for 5 or more days. Grade 3 includes treatment of sepsis, endocarditis, invasive infection, or infection leading to respiratory failure. Grade 4 is death due to infection. A higher number of participants on this measure indicates a better outcome.
Time frame: From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity PTLD Event
Number of participants who are "free from" (have NOT experienced) a post-transplant lymphoproliferative disease MATE of Grade 2 or greater. A higher number of participants on this measure indicates a better outcome.
Time frame: From enrollment to 30 months after enrollment
Efficacy: Freedom From Composite of CAV, CKD, BP-ACR, or Any CMV Infection
Number of participants who are "free from" (have NOT experienced) at least one of cardiac allograft vasculopathy, chronic kidney disease with estimated glomerular filtration rate less than or equal to 60 ml/min/1.73m2, treated acute cellular rejection, or any cytomegalovirus infection. A higher number of participants on this measure indicates a better outcome.
Time frame: From enrollment to 30 months after enrollment
Efficacy: Change in CKD Stage
Change in chronic kidney disease stage where improvements in CKD stage can take on a negative value.
Time frame: Baseline visit through 30 months post-randomization
Efficacy: MATE-3 Score Where CKD Score is Calculated by Change From Baseline Visit
MATE-3 is a validated score ranging from 0 to 12. The score adds together each subscore so that it represents the cumulative burden of three major adverse transplant events: Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). For this version of the score, the chronic kidney disease score is replaced by the change in MATE-CKD score from baseline visit through 30 months post-randomization. CKD change score can assume a negative value. This modified score can range from -2 to 12. A higher score represents a worse outcome.
Time frame: Baseline visit through 30 months post-randomization
Efficacy: MATE-3 Score Where CKD Score is Replaced by Change in CKD Stage
MATE-3 is a validated score ranging from 0 to 12. The score adds together each subscore so that it represents the cumulative burden of three major adverse transplant events: Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). For this version of the score, the chronic kidney disease score is replaced by the change in chronic kidney disease stage from the baseline visit through 30 months post-randomization. Chronic kidney disease stage change score can assume a negative value. This modified score can range from -2 to 12. A higher score represents a worse outcome.
Time frame: Baseline visit through 30 months post-randomization
Efficacy: Composite Score Consisting of MATE CAV, MATE BP-ACR, MATE CKD Score, and Any CMV Infection.
Composite score ranging from 0 to 16. The score adds each subscore to represent the cumulative burden of three major adverse transplant events plus CMV infection. The three major adverse transplant events are Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). Any CMV infection is assigned a score of 1 with additional points using the MATE infection scoring criteria. Full details of the score can be found in the protocol. A higher score represents a worse outcome.
Time frame: Baseline visit through 30 months post-randomization
Efficacy: Composite Score Consisting of MATE CAV, MATE BP-ACR, Change in CKD Stage, and Any CMV Infection.
Composite score ranging from -2 to 16. The score adds each subscore to represent the cumulative burden of Cardiac Allograft Vasculopathy (CAV), chronic kidney disease, and Biopsy-proven Acute Cellular Rejection (ACR). Any CMV infection is assigned a score of 1 with additional points using the MATE infection scoring criteria. The chronic kidney disease MATE score is replaced by change in CKD stage. A higher score represents a worse outcome.
Time frame: Baseline visit through 30 months post-randomization
Efficacy: Lansky Scores
Validated functional performance score, assigned by clinician assessment: Lansky score is assigned if \< 16 years old at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Time frame: Baseline
Efficacy: Lansky Scores
Validated functional performance score, assigned by clinician assessment: Lansky score is assigned if \< 16 years old at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Time frame: 18 months post-randomization
Efficacy: Lansky Scores
Validated functional performance score, assigned by clinician assessment: Lansky score is assigned if \< 16 years old at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Time frame: 30 months post-randomization
Efficacy: Karnofsky Scores
Validated functional performance score, assigned by clinician assessment: Karnofsky score is assigned if \>=16 years at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Time frame: Baseline
Efficacy: Karnofsky Scores
Validated functional performance score, assigned by clinician assessment: Karnofsky score is assigned if \>=16 years at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Time frame: 18 months post-randomization
Efficacy: Karnofsky Scores
Validated functional performance score, assigned by clinician assessment: Karnofsky score is assigned if \>=16 years at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Time frame: 30 months post-randomization
Heart transplant recipients who were alive 6 months after their heart transplant procedure were recruited at 25 pediatric heart transplant hospitals in the United States from January 2018 to August 2020.
| Milestone | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Started | 107 | 104 |
| Completed | 107 | 100 |
| Not completed | 0 | 4 |
| Withdrew: Lost to follow-up | 0 | 3 |
| Withdrew: Withdrawal by subject | 0 | 1 |
MATE-3 is a validated score ranging from 0 to 12. The score adds together each subscore so that it represents the cumulative burden of three major adverse transplant events: Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). Complete details of the score can be found in the study protocol. A higher score represents a worse outcome.
| Scores on a scale | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| EFFICACY: MATE-3 Score | 0.9 ± 2.2 | 1.3 ± 2.5 |
MATE-6 is a validated score ranging from 0 to 24. The score adds together each subscore so that it represents the cumulative burden of all six major adverse transplant events: Coronary Artery Vasculopathy (CAV), Chronic Kidney Disease (CKD), Biopsy-proven Acute Cellular Rejection (ACR), pathologic diagnosis of Antibody-Mediated Rejection (AMR), Infection, and Post-Transplant Lymphoproliferative Disorder (PTLD). Complete details of the score can be found in the study protocol. A higher score represents a worse outcome.
| Scores on a scale | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| SAFETY: MATE-6 Score | 2.0 ± 4.6 | 2.4 ± 5.2 |
Number of participants who experienced death from any cause
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: Overall Patient Survival | 3 | 3 |
Number of participants who experienced death or heart re-transplantation
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: Overall Allograft Survival | 4 | 5 |
Change in estimated glomerular filtration rate (eGFR) using the modified Schwartz equation. A positive number indicates improved kidney function, a negative number indicates worsened kidney function.
| ml/min/1.73 m^2 | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Change from baseline to 6 months post-randomization | 20.5 ± 32.7 | 11.9 ± 31.1 |
| Change from baseline to 12 months post-randomization | 15.4 ± 35.2 | 4.9 ± 32.7 |
| Change from baseline to 30 months post-randomization | 8.6 ± 32.3 | 5.2 ± 37.4 |
Number of participants who are "free from" (have NOT experienced) a chronic kidney disease MATE. A chronic kidney disease MATE was defined as an eGFR \< 60 ml/min/1.73 m\^2 during follow-up or worsening by at least one MATE score if \< 60 ml/min/1.73 m\^2 at baseline. A higher number of participants on this measure indicates a better outcome.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: Freedom From CKD Event | 105 | 99 |
Number of participants who are "free from" (have NOT experienced) cardiac allograft vasculopathy (CAV) during follow up as graded by the angiography core laboratory. A higher number of participants on this measure indicates a better outcome.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: Freedom From CAV Event | 80 | 73 |
Number of participants who are "free from" (have NOT experienced) biopsy-proven Acute Cellular Rejection (ACR) MATE event during follow-up. A higher number of participants on this measure indicates a better outcome.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: Freedom From BP-ACR Event | 92 | 89 |
Number of participants who are "free from" (have NOT experienced) the composite of death, graft loss, 2R/3R acute cellular rejection or rejection with hemodynamic compromise. A higher number of participants on this measure indicates a better outcome.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: Freedom From Composite Failure | 94 | 85 |
The EuroQOL EQ-5D Y uses a visual-analog scale and asks the participant to mark an X on the line to show how good or bad your is health TODAY. The scale ranges from 0 to 100.
| Scores on a scale | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: EuroQOL EQ-5D Y (Youth Version) | 91.5 ± 14.6 | 90.0 ± 12.3 |
Number of participants who are "free from" (have NOT experienced) a pathologic diagnosis of Antibody-Mediated Rejection (AMR) MATE Event. A higher number of participants on this measure indicates a better outcome.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Safety: Freedom From AMR | 103 | 98 |
Number of participants who are "free from" (have NOT experienced) a serious infection MATE during follow-up. A higher number of participants on this measure indicates a better outcome.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Safety: Freedom From Infection | 80 | 82 |
Number of participants who are "free from" (have NOT experienced) a Post-Transplant Lymphoproliferative Disorder (PTLD) MATE event during follow-up. A higher number of participants on this measure indicates a better outcome.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Safety: Freedom From PTLD | 105 | 103 |
Adverse events reported throughout the study. Adverse events are classified by CTCAE classification. Serious adverse events include CTCAE classes 3, 4, and 5.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Any adverse event | 103 | 99 |
| Serious adverse events | 75 | 59 |
Number of participants who are "free from" (have NOT experienced) any MATE event, this includes chronic kidney disease, cardiac allograft vasculopathy, acute cellular rejection, antibody mediated rejection, serious infection, and post-transplant lymphoproliferative disease. A higher number of participants on this measure indicates a better outcome.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Safety: Freedom From Major Transplant Events (Composite) | 52 | 45 |
Number of participants who are "free from" (have NOT experienced) a chronic kidney disease MATE of Grade 2 or greater (eGFR \<45 ml/min/1.73 m\^2 or on dialysis) or death due to chronic kidney disease. A higher number of participants on this measure indicates a better outcome.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Safety: Freedom From Grade 2 or Greater Severity CKD Event | 106 | 104 |
Number of participants who are "free from" (have NOT experienced) a cardiac allograft vasculopathy MATE of Grade 2 or greater. Grade 2 or greater is the same as having International Society of Heart and Lung Transplantation cardiac allograft vasculopathy Grade 2 or 3 or death due to cardiac allograft vasculopathy. A higher number of participants on this measure indicates a better outcome.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Safety: Freedom From Grade 2 or Greater Severity CAV Event | 98 | 90 |
Number of participants who are "free from" (have NOT experienced) an acute cellular rejection MATE of Grade 2 or greater. Grade 2 or greater is the equivalent of treated rejection with an assigned International Society of Heart \& Lung Transplantation acute cellular rejection grade 2 or grade 3 or rejection with hemodynamic compromise (decreased ejection fraction, need for IV medicine to support heart, need for mechanical circulatory support) or death due to acute cellular rejection. A higher number of participants on this measure indicates a better outcome.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Safety: Freedom From Grade 2 or Greater Severity ACR Event | 95 | 89 |
Number of participants who are "free from" (have NOT experienced) an antibody mediated rejection MATE of Grade 2 or greater. Grade 2 or greater is the equivalent of treated rejection with an assigned International Society of Heart \& Lung Transplantation antibody mediated rejection grade 2 or grade 3 or antibody mediated rejection with hemodynamic compromise (decreased ejection fraction, need for IV medicine to support heart, need for mechanical circulatory support) or death due to antibody mediated rejection. A higher number of participants on this measure indicates a better outcome.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Safety: Freedom From Grade 2 or Greater Severity AMR Event | 103 | 98 |
Number of participants who are "free from" (have NOT experienced) a serious infection MATE of Grade 2 or greater. Grade 2 infections require treatment with intravenous antibiotics or antivirals for 5 or more days. Grade 3 includes treatment of sepsis, endocarditis, invasive infection, or infection leading to respiratory failure. Grade 4 is death due to infection. A higher number of participants on this measure indicates a better outcome.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Safety: Freedom From Grade 2 or Greater Severity Infection Event | 94 | 97 |
Number of participants who are "free from" (have NOT experienced) a post-transplant lymphoproliferative disease MATE of Grade 2 or greater. A higher number of participants on this measure indicates a better outcome.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Safety: Freedom From Grade 2 or Greater Severity PTLD Event | 105 | 103 |
Number of participants who are "free from" (have NOT experienced) at least one of cardiac allograft vasculopathy, chronic kidney disease with estimated glomerular filtration rate less than or equal to 60 ml/min/1.73m2, treated acute cellular rejection, or any cytomegalovirus infection. A higher number of participants on this measure indicates a better outcome.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: Freedom From Composite of CAV, CKD, BP-ACR, or Any CMV Infection | 59 | 43 |
Change in chronic kidney disease stage where improvements in CKD stage can take on a negative value.
| Participants | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| -2 (Improvement by 2 CKD Stages) | 1 | 1 |
| -1 (Improvement by 1 CKD Stage) | 12 | 15 |
| 0 (No change in CKD Stage) | 78 | 64 |
| 1 (Worsening by 1 CKD Stage) | 9 | 8 |
MATE-3 is a validated score ranging from 0 to 12. The score adds together each subscore so that it represents the cumulative burden of three major adverse transplant events: Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). For this version of the score, the chronic kidney disease score is replaced by the change in MATE-CKD score from baseline visit through 30 months post-randomization. CKD change score can assume a negative value. This modified score can range from -2 to 12. A higher score represents a worse outcome.
| Points | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: MATE-3 Score Where CKD Score is Calculated by Change From Baseline Visit | 0.89 ± 2.16 | 1.17 ± 2.49 |
MATE-3 is a validated score ranging from 0 to 12. The score adds together each subscore so that it represents the cumulative burden of three major adverse transplant events: Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). For this version of the score, the chronic kidney disease score is replaced by the change in chronic kidney disease stage from the baseline visit through 30 months post-randomization. Chronic kidney disease stage change score can assume a negative value. This modified score can range from -2 to 12. A higher score represents a worse outcome.
| Points | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: MATE-3 Score Where CKD Score is Replaced by Change in CKD Stage | 0.84 ± 2.22 | 1.10 ± 2.56 |
Composite score ranging from 0 to 16. The score adds each subscore to represent the cumulative burden of three major adverse transplant events plus CMV infection. The three major adverse transplant events are Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). Any CMV infection is assigned a score of 1 with additional points using the MATE infection scoring criteria. Full details of the score can be found in the protocol. A higher score represents a worse outcome.
| Scores on a scale | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: Composite Score Consisting of MATE CAV, MATE BP-ACR, MATE CKD Score, and Any CMV Infection. | 1.06 ± 2.17 | 1.51 ± 2.46 |
Composite score ranging from -2 to 16. The score adds each subscore to represent the cumulative burden of Cardiac Allograft Vasculopathy (CAV), chronic kidney disease, and Biopsy-proven Acute Cellular Rejection (ACR). Any CMV infection is assigned a score of 1 with additional points using the MATE infection scoring criteria. The chronic kidney disease MATE score is replaced by change in CKD stage. A higher score represents a worse outcome.
| Scores on a scale | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: Composite Score Consisting of MATE CAV, MATE BP-ACR, Change in CKD Stage, and Any CMV Infection. | 0.97 ± 2.21 | 1.36 ± 2.55 |
Validated functional performance score, assigned by clinician assessment: Lansky score is assigned if \< 16 years old at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
| Scores on a scale | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: Lansky Scores | 93.83 ± 10.12 | 92.45 ± 10.12 |
Validated functional performance score, assigned by clinician assessment: Lansky score is assigned if \< 16 years old at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
| Scores on a scale | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: Lansky Scores | 95.42 ± 8.45 | 94.77 ± 7.99 |
Validated functional performance score, assigned by clinician assessment: Lansky score is assigned if \< 16 years old at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
| Scores on a scale | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: Lansky Scores | 94.55 ± 12.86 | 94.73 ± 10.46 |
Validated functional performance score, assigned by clinician assessment: Karnofsky score is assigned if \>=16 years at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
| Scores on a scale | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: Karnofsky Scores | 92.22 ± 8.33 | 91.67 ± 8.35 |
Validated functional performance score, assigned by clinician assessment: Karnofsky score is assigned if \>=16 years at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
| Scores on a scale | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: Karnofsky Scores | 95 ± 7.07 | 93.75 ± 7.72 |
Validated functional performance score, assigned by clinician assessment: Karnofsky score is assigned if \>=16 years at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
| Scores on a scale | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Efficacy: Karnofsky Scores | 91 ± 19.12 | 94.27 ± 7.13 |
Collected over From consent until end of follow-up, up to 33 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Everolimus/Low-Dose Tacrolimus | 3/107 (2.8%) | 76/107 (71%) | 101/107 (94.4%) |
| Tacrolimus/Mycophenolate Mofetil | 3/104 (2.9%) | 60/104 (57.7%) | 100/104 (96.2%) |
| Event | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Immune system disorders - Other, specifyImmune system disorders | 13/107 | 19/104 |
| Lung infectionInfections and infestations | 19/107 | 16/104 |
| Infections and infestations - Other, specifyInfections and infestations | 17/107 | 13/104 |
| DehydrationMetabolism and nutrition disorders | 12/107 | 8/104 |
| Gastrointestinal disorders - Other, specifyGastrointestinal disorders | 12/107 | 8/104 |
| Upper respiratory infectionInfections and infestations | 9/107 | 5/104 |
| Respiratory, thoracic and mediastinal disorders - OtherRespiratory, thoracic and mediastinal disorders | 7/107 | 6/104 |
| AnemiaBlood and lymphatic system disorders | 2/107 | 6/104 |
| Vascular disorders - Other, specifyVascular disorders | 2/107 | 6/104 |
| Investigations - Other, specifyInvestigations | 5/107 | 1/104 |
| Event | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil |
|---|---|---|
| Infections and infestations - Other, specifyInfections and infestations | 43/107 | 36/104 |
| Mucositis oralGastrointestinal Disorders | 33/107 | 7/104 |
| Upper respiratory infectionInfections and infestations | 31/107 | 29/104 |
| Gastrointestinal disorders - Other, specifyGastrointestinal Disorders | 18/107 | 28/104 |
| Skin and subcutaneous tissue disorders - Other, specifySkin and subcutaneous tissue disorders | 23/107 | 24/104 |
| Otitis mediaInfections and infestations | 24/107 | 18/104 |
| Immune system disorders - Other, specifyImmune system disorders | 16/107 | 21/104 |
| DiarrheaGastrointestinal Disorders | 21/107 | 19/104 |
| Investigations - Other, specifyInvestigations | 19/107 | 7/104 |
| CoughRespiratory, thoracic and mediastinal disorders | 12/107 | 14/104 |
All patients randomized are included in this table.
| Age, Customized(Participants) | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil | Total |
|---|---|---|---|
| < 1 year of age | 22 | 13 | 35 |
| 1 to < 6 years of age | 32 | 25 | 57 |
| 6 to < 12 years of age | 17 | 24 | 41 |
| 12 to < 18 years of age | 35 | 35 | 70 |
| Greater than or equal to 18 years of age | 1 | 7 | 8 |
| Sex: Female, Male(Participants) | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil | Total |
|---|---|---|---|
| Female | 48 | 50 | 98 |
| Male | 59 | 54 | 113 |
| Race (NIH/OMB)(Participants) | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 5 | 7 | 12 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 12 | 8 | 20 |
| White | 84 | 84 | 168 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 4 | 4 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil | Total |
|---|---|---|---|
| Hispanic or Latino | 23 | 29 | 52 |
| Not Hispanic or Latino | 83 | 72 | 155 |
| Unknown or Not Reported | 1 | 3 | 4 |
| Chronic kidney disease stage(Participants) | Everolimus/Low-Dose Tacrolimus | Tacrolimus/Mycophenolate Mofetil | Total |
|---|---|---|---|
| Stage 1/2 | 106 | 101 | 207 |
| Stage 3A | 1 | 3 | 4 |
| Stage 3B | 0 | 0 | 0 |
| Stage 4/5 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Apr 2023, 62 months.
Results were first posted in Jul 2026, 3 years 3 months after primary completion.
Of 41 non-industry phase 3 interventional studies under Renal Insufficiency, Chronic, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 69. This study's 62 months is above that.
Counting every sponsor, half of 145 studies reached it within 33 months; a quarter within 19 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Everolimus
Renal Insufficiency, Chronic →