A Phase 3 interventional study of Tacrolimus and Tacrolimus Extended Release Oral Tablet [Envarsus] in End Stage Renal Disease and Rejection of Renal Transplant, sponsored by Lorenzo Gallon. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-10.
Sponsored by Lorenzo Gallon · Phase 3, Interventional, and Treatment
Among 13 studies testing tacrolimus in Kidney Failure, Chronic — 1 open to participants now, 2 under way, 1 of them phase 3. Tacrolimus · Kidney Failure, Chronic.
Among the 13 studies testing tacrolimus in Kidney Failure, Chronic, this one is the 9th largest by enrollment, is one of 2 that started in 2017, is the only one in phase 3, and was the 10th registered.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 29 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →1 of the 13 studies testing tacrolimus in Kidney Failure, Chronic is open now, in 1 country. Each count lists the studies.
Tacrolimus: first FDA approval 1994 (PROGRAF), first EMA approval 2002. What it is approved for, and how studies give it, is on its page →
Of the 170 Kidney Failure, Chronic studies recruiting now, 109 (64%) set no upper age limit and 32 (19%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 2 started in 2017.
Median enrollment 46 across the 13 interventional studies. Of the 11 that completed or were terminated, 4 (36%) have results posted.
2 of 13 have an industry lead sponsor. The 10 most frequent:
Lorenzo Gallon is the lead sponsor of 2 studies on the registry; none are open to participants now.
Lorenzo Gallon has 1 study filed under Kidney Failure, Chronic — fewer than ten, so there is no comparison to draw.
1 of the studies testing tacrolimus in Kidney Failure, Chronic that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03321656Phase 3Roberto GedalyImpact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile | 2027-03-31 |
Among the 13 studies testing tacrolimus in Kidney Failure, Chronic, from their registry updates:
Nothing recorded among them since 2026-09-25.
The overall aim of the study is to prospectively investigate the impact of two maintenance calcineurin inhibitor immunosuppressive regimens: once-daily extended release tacrolimus and twice-daily tacrolimus on subpopulations of T and B cells and alloreactive T cells as well as on renal allograft function.
Kidney transplantation is the treatment of choice for most patients with end-stage renal disease. Lifelong immunosuppressive therapies are required to prevent organ rejection. However, long term exposure to immunosuppressive therapy after kidney transplantation can place patients at risk for multiple adverse events. The optimal immunosuppressive therapy is not well established. Tacrolimus, a calcineurin inhibitor (CNI) is highly effective in preventing acute rejection after organ transplantation (2). It is used as part of the immunosuppression regimen for the majority of kidney and liver transplant recipients (3). However, treatment with current formulation of Tacrolimus generates high peaks and low troughs in drug concentrations in the blood. It is known that high exposure to CNI is associated with renal toxicities and adverse events (4). New once-daily dosage formulations are now developed with the hope of minimizing side effects while maintaining excellent outcomes (5-8).
LCP-Tacro (Envarsus® XR, Veloxis Pharmaceuticals), a new once-daily formulation of tacrolimus, was approved by the FDA in 2015 for conversion from twice-daily tacrolimus in kidney transplant recipients. It is a prolonged-release tacrolimus formulation, utilizing a MeltDose drug delivery technology designed to improve the bioavailability of drugs with low water solubility (1). Recent clinical data demonstrated that once-daily LCP-Tacro has improved pharmacokinetic bioavailability, rapid achievement of therapeutic trough levels, less fluctuation and swing in whole blood concentration, non-inferior efficacy and similar safety, with lower tacrolimus dose than other tacrolimus formulations.
The target population is adult recipients of immediately functioning living and deceased donor renal allografts. Immediate function will be defined as the absence of the need for hemodialysis in the first week following renal transplantation.
Prospective randomized single center open label study of 2 groups of kidney transplant patients
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:
Significant cardiovascular disease (e.g.):
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Tacrolimus
Drug: Tacrolimus Extended Release Oral Tablet [Envarsus]
immunosuppressive agent tacrolimus, given twice-daily
immunosuppressive agent extended-release tacrolimus, given once daily
Also known as: LCP-tacro
Change in Kidney Transplant Function From 2 Weeks Post Transplant Through 12 Months Post Transplant
change in the mean eGFR from the baseline (2 weeks post transplant), 3 months (post transplant) , and 12 months (post transplant).
Time frame: 2 weeks post transplant through 12 months post transplant
Change in Subpopulations of T Cells From 2 Weeks Post Transplant Through 12 Months Post Transplant
Blood, urine and kidney tissue analysis via serial flow cytometric immunophenotyping (includes regulatory T and B cell populations as well as immune functions).
Time frame: Measured at 2 weeks post transplant, 3 months post transplant, 12 months post transplant
Number of Participants With Acute Rejection at 3 Months and 12 Months Post-Transplant
Acute rejection of kidney transplant is determined via biopsy.
Time frame: Measured at 3 months post transplant, 12 months post transplant
Number of Participants With Graft Loss at 3 Months and 12 Months Post-Transplant
Graft loss is determined via biopsy.
Time frame: Measured at 3 months post transplant, 12 months post transplant
Number of Subjects Deceased at at 3 Months and 12 Months Post-Transplant
Subject survival status is continually monitored via routine follow-up visits.
Time frame: Through 12 months post transplant
Number of Participants With Change in Allograft Immunohistopathology Profile
Tissue analysis via immunohistopathological staining and microscopic examination Moderate acute tubular necrosis =\> presence of focal coagulative necrosis or infarction on histopathologic examination Arteriolar hyalinosis grade 2 means: Replacement of degenerated smooth muscle cells by hyaline deposits in more than 1 arteriole, without circumferential involvement Global glomerulosclerosis \>grade 2, means glomerulosclerosis affecting more than 50% of glomeruli in the biopsy sample IFTA : Interstitial fibrosis and tubular atrophy: Inflammation in 26% to 50% of scarred cortical parenchyma
Time frame: Measured at 3 months post transplant, 12 months post transplant
| Milestone | Group 1: Control Arm: Standard of Care (SOC) Tacrolimus | Group 2: Interventional Arm: Study Related Drug: LCP-Tacrolimus/Envarsus XR (LCP-Tacro/Envarsus XR) |
|---|---|---|
| Started | 14 | 15 |
| Completed | 14 | 15 |
| Not completed | 0 | 0 |
change in the mean eGFR from the baseline (2 weeks post transplant), 3 months (post transplant) , and 12 months (post transplant).
| mL/min/1.73m^2 | Group 1: Control Arm: Standard of Care (SOC) Tacrolimus | Group 2: Interventional Arm: Study Related Drug: LCP-Tacrolimus/Envarsus XR (LCP-Tacro/Envarsus XR) |
|---|---|---|
| Change in Kidney Transplant Function From 2 Weeks Post Transplant Through 12 Months Post Transplant | 2.03 ± 1.71 | -2.19 ± 1.77 |
Blood, urine and kidney tissue analysis via serial flow cytometric immunophenotyping (includes regulatory T and B cell populations as well as immune functions).
No measurements were reported for this outcome.
Acute rejection of kidney transplant is determined via biopsy.
| Participants | Group 1: Control Arm: Standard of Care (SOC) Tacrolimus | Group 2: Interventional Arm: Study Related Drug: LCP-Tacrolimus/Envarsus® XR (LCP-Tacro/Envarsus XR) |
|---|---|---|
| Acute rejection at 3 months | 0 | 1 |
| Acute rejection at 12 months | 0 | 2 |
Graft loss is determined via biopsy.
| Participants | Group 1: Control Arm: Standard of Care (SOC) Tacrolimus | Group 2: Interventional Arm: Study Related Drug: LCP-Tacrolimus/Envarsus XR (LCP-Tacro/Envarsus XR) |
|---|---|---|
| Graft Loss at 3 months | 0 | 0 |
| Graft loss at 12 months | 0 | 0 |
Subject survival status is continually monitored via routine follow-up visits.
| Participants | Group 1: Control Arm: Standard of Care (SOC) Tacrolimus | Group 2: Interventional Arm: Study Related Drug: LCP-Tacrolimus/Envarsus® XR (LCP-Tacro/Envarsus XR) |
|---|---|---|
| Subject Death at 3 months | 0 | 0 |
| Subject Death at 12 months | 0 | 0 |
Tissue analysis via immunohistopathological staining and microscopic examination Moderate acute tubular necrosis =\> presence of focal coagulative necrosis or infarction on histopathologic examination Arteriolar hyalinosis grade 2 means: Replacement of degenerated smooth muscle cells by hyaline deposits in more than 1 arteriole, without circumferential involvement Global glomerulosclerosis \>grade 2, means glomerulosclerosis affecting more than 50% of glomeruli in the biopsy sample IFTA : Interstitial fibrosis and tubular atrophy: Inflammation in 26% to 50% of scarred cortical parenchyma
| Participants | Group 1: Control Arm: Standard of Care (SOC) Tacrolimus | Group 2: Interventional Arm: Study Related Drug: LCP-Tacrolimus/Envarsus XR (LCP-Tacro/Envarsus XR) |
|---|---|---|
| Acute tubular necrosis > moderate >=2 | 2 | 2 |
| Arteriolar Hyalinosis >= grade 2 | 2 | 2 |
| isometric vacuolization of tubules | 0 | 1 |
| Arteriolar myocyte vacuolization | 0 | 0 |
| Thrombotic microangiopathy | 1 | 1 |
| Global glomerulosclerosis >grade 2 | 1 | 2 |
| IFTA > grade 2 | 1 | 2 |
Collected over Adverse events were reviewed at 1 year after tranplant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care Tacrolimus Twice-daily | 0/14 (0%) | 0/14 (0%) | 7/14 (50%) |
| Extended-release Tacrolimus Once-daily | 0/15 (0%) | 1/15 (6.7%) | 5/15 (33.3%) |
| Event | Standard of Care Tacrolimus Twice-daily | Extended-release Tacrolimus Once-daily |
|---|---|---|
| HospitalizationsRenal and urinary disorders | 0/14 | 1/15 |
| Event | Standard of Care Tacrolimus Twice-daily | Extended-release Tacrolimus Once-daily |
|---|---|---|
| LeukopeniaImmune system disorders | 4/14 | 4/15 |
| BK ViremiaRenal and urinary disorders | 2/14 | 0/15 |
| InfectionsImmune system disorders | 1/14 | 1/15 |
| MalignancyImmune system disorders | 0/14 | 0/15 |
| Age, Continuous(years) | Standard of Care Tacrolimus Twice-daily | Extended-release Tacrolimus Once-daily | Total |
|---|---|---|---|
| Mean | 43.14 ± 12.7 | 47.53 ± 16.04 | 45.4 ± 14.4 |
| Sex: Female, Male(Participants) | Standard of Care Tacrolimus Twice-daily | Extended-release Tacrolimus Once-daily | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 11 | 12 | 23 |
| Race (NIH/OMB)(Participants) | Standard of Care Tacrolimus Twice-daily | Extended-release Tacrolimus Once-daily | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 10 | 13 | 23 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Cause of Kidney Disease(participants) | Standard of Care Tacrolimus Twice-daily | Extended-release Tacrolimus Once-daily | Total |
|---|---|---|---|
| Diabetes | 3 | 4 | 7 |
| Glomerulonephritis | 3 | 4 | 7 |
| Obstructive Nephropathy | 2 | 0 | 2 |
| Congenital | 1 | 2 | 3 |
| Others | 5 | 5 | 10 |
| Type of Donor(Participants) | Standard of Care Tacrolimus Twice-daily | Extended-release Tacrolimus Once-daily | Total |
|---|---|---|---|
| Cadaveric | 0 | 1 | 1 |
| Living | 14 | 14 | 28 |
| Panel reactive antibodies (PRA)(percentage) | Standard of Care Tacrolimus Twice-daily | Extended-release Tacrolimus Once-daily | Total |
|---|---|---|---|
| Major histocompatibility complex class I (MHC-I) antibodies | 1.93 ± 2.79 | 4.20 ± 8.44 | 3.1 ± 6.4 |
| Major histocompatibility complex class II (MHC-II) antibodies | 3.07 ± 5.18 | 4.07 ± 9.01 | 3.6 ± 7.3 |
| Estimated glomerular filtration rate (eGFR)(ml/min/1.73m2) | Standard of Care Tacrolimus Twice-daily | Extended-release Tacrolimus Once-daily | Total |
|---|---|---|---|
| Median | 52.43 ± 9.26 | 51.77 ± 9.69 | 52.1 ± 10.6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2017 to primary completion in Feb 2021, 41 months.
Results were first posted in Apr 2023, 2 years 1 month after primary completion.
Of 66 phase 3 interventional studies under Kidney Failure, Chronic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 48. This study's 41 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tacrolimus
Lorenzo Gallon