A Phase 4 interventional study of belatacept and Tacrolimus in Transplant; Failure, Kidney and EBV, sponsored by Lorenzo Gallon. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Lorenzo Gallon · Phase 4, Interventional, and Treatment
Among 552 studies in Renal Insufficiency with a site in United States — 39 open to participants now, 56 under way, 3 of them phase 3. Renal Insufficiency · United States.
Among the 552 studies in Renal Insufficiency with a site in United States, this one is the 267th largest by enrollment of the 467 interventional ones, is one of 23 that started in 2014, is one of 44 in phase 4, and was the 283rd registered.
1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.
This study's enrollment of 28 is below the median of 40 across 1,058 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →39 of the 552 studies in Renal Insufficiency with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 90 Renal Insufficiency studies recruiting now, 47 (52%) set no upper age limit and 18 (20%) stop at 75 or younger; 8 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →552 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 23 started in 2014.
Median enrollment 32 across the 467 interventional studies, 182 across the 82 observational. Of the 464 that completed or were terminated, 169 (36%) have results posted.
333 of 552 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 Renal Insufficiency — fewer than ten, so there is no comparison to draw.
23 of the studies in Renal Insufficiency with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04020055Phase 3Amicus TherapeuticsA Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease | 2026-12-31 |
| NCT07341516Paris Translational Research Center for Organ TransplantationWorldwide Assessment of Deceased Donor Kidney Utilization | 2026-11 |
| NCT06004661Novartis PharmaceuticalsStudy of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function | 2026-11-06 |
| NCT04605679Loma Linda UniversityHepatitis C Virus (HCV) Positive Kidney Grafts in HCV Negative Recipients | 2026-12 |
| NCT07857837ShionogiStudy of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls | 2026-12-04 |
Among the 552 studies in Renal Insufficiency with a site in United States, from their registry updates:
This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months after kidney transplantation. The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking the transplanted organ. The primary purpose of this research study is to evaluate the effects of three (3) different immunosuppressive treatments on rejection in post-transplant kidney recipients. This study will test whether switching from tacrolimus to belatacept will improve long-term kidney function.
Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug Administration (FDA) to be used after transplant. All of these medications have been routinely used in kidney recipients here at Northwestern University.
Belatacept (the "study drug") has been approved by the FDA for use at the time of transplant. However, the use of belatacept in this study is considered investigational as it has not been FDA approved for use beginning at 3 months after transplant.
This study will involve 51 adult kidney transplant recipients at Northwestern.
Immunosuppressive therapy with the calcineurin inhibitors (CNI) cyclosporine (CsA) and Tacrolimus (Tac), have radically changed the field of organ transplantation. Ironically, although extensively and effectively used for kidney transplantation and other solid organ transplants, CsA and Tac cause important adverse renal side effects: acute and chronic renal dysfunction, hemolytic-uremic syndrome, hypertension, electrolyte disturbances and tubular acidosis. Chronic nephrotoxicity from CNI has been implicated as a principal cause of post-transplant renal dysfunction and it is characterized by an irreversible and progressive tubular atrophy, interstitial fibrosis, and focal hyalinosis of small renal arteries and arterioles. Attempts to minimize CNIs and their known toxicities have been marginally successful due to unacceptable rates of acute rejection and drug toxicity. Patients are converted to alternative immunosuppressive therapy related to CNI side effects including neurotoxicity, nephrotoxicity, cardiovascular (HTN, hyperlipidemia), metabolic (NODAT), and cosmetic side effects. Furthermore, this class of medications is associated also, by blocking Interleukin 2 (IL2) production, with negative impact on regulatory T cells (Tregs) generation (an important subpopulation of T helper cells that has been associated with positive immunomodulation and donor specific hypo-responsiveness).
Until the approval of Belatacept for adult EBV+ renal transplant recipients, there have been limited alternative immunosuppressive agents available to mitigate drug induced renal impairment. The phase III drug trials of Belatacept in combination with MMF and corticosteroids have resulted in significant and sustained improvement in glomerular filtration rate (GFR) at one year through three years post transplant. The overall safety of belatacept compared to cyclosporine in de novo transplant recipients was similar. However, there was an increased rate and severity of early acute rejection and post-transplant lymphoproliferative disorder (PTLD) of the central nervous system in patients treated with belatacept.
In a phase II switch study conducted by Bristol Myers Squibb (BMS), the incidence of acute rejection at 24 months post conversion was similar in patients remaining on CNI (4%) compared to those converted to belatacept (7%). There were no reported cases of post-transplant lymphoproliferative disorder (PTLD) in this patient population as of two years post randomization. However, one belatacept patient from Mexico developed tuberculosis and there were more non-serious fungal infections in the belatacept treated patients.
Mechanistically, CD28 (Cluster of Differentiation 28) and CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) are important for the function of regulatory T cells (Tregs). Belatacept binds to CD80/CD86 (Cluster of Differentiation 80/Cluster of Differentiation 86) ligands on antigen presenting cells (APCs) preventing CD28 to bind with these ligands and deliver the costimulatory signal to activate the T Cell. CTLA-4 is a related receptor expressed on activated T cells that also recognizes CD80/CD86 (Cluster of Differentiation 80/Cluster of Differentiation 86) and is thus termed co-inhibitory. It transmits both cell intrinsic and cell extrinsic negative signals that impair activation.
Investigation of the effect of early conversion to Belatacept at month 3 post-transplant on the subpopulations of T cells and B cells and peripheral blood and allograft biopsy-derived gene expression subpopulation profiles are planned. Optimization of the Belatacept immunosuppressive regimen to achieve good long term renal function and improved graft survival requires understanding the relationships of these cell populations to clinical outcomes.
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 biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
subjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus: Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter. Tacrolimus tapered over one month as follows: Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 40-60% of the previous dose Day 21 (\~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue MPA: administered according to SOC
Drug: belatacept · Drug: MPA
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter. Tacrolimus tapered over one month as follows: Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 10% of the previous dose Day 21 (\~ 3 weeks into study): 20% of the previous dose Day 30 (\~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter.
Drug: belatacept · Drug: Tacrolimus
Standard of Care treatment regimen: Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter. MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper. MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator.
Drug: Tacrolimus · Drug: MPA
Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
Also known as: Belatacept (Nulojix®)
Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
Also known as: Tacrolimus (Prograf®)
Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
Also known as: Mycophenolic Acid (MPA) (Myfortic®)
Change in eGFR (MDRD) at 2 Years Post-transplant Compared to Baseline at Month 3 (Conversion)
To assess change in renal function by calculated (MDRD) GFR of adult EBV seropositive renal transplant recipients of living or standard criteria donors converted from Tacrolimus to Belatacept or low dose Tacrolimus with Belatacept at three months post-operatively compared to renal transplant recipients randomized to remain on standard dose Tacrolimus and MPA for maintenance therapy at 2 years post-transplantation
Time frame: 2 years
Acute Rejection
Number of Participants with Acute Rejection (AR). AR is defined as allograft dysfunctions in the setting of recipient immune system engaging an allo-response against the kidney transplant.
Time frame: 2 years
Graft Survival
Number of Subjects with a functioning Graft
Time frame: 2 years
Patient Survival
Number of Subjects alive at the end of 24 months
Time frame: 2 years
| Milestone | Belatacept + MPA | Belatacept + Low-Dose Tac | Tacrolimus + MPA Standard Treatment Regimen |
|---|---|---|---|
| Started | 9 | 8 | 10 |
| Completed | 9 | 8 | 10 |
| Not completed | 0 | 0 | 0 |
To assess change in renal function by calculated (MDRD) GFR of adult EBV seropositive renal transplant recipients of living or standard criteria donors converted from Tacrolimus to Belatacept or low dose Tacrolimus with Belatacept at three months post-operatively compared to renal transplant recipients randomized to remain on standard dose Tacrolimus and MPA for maintenance therapy at 2 years post-transplantation
| mL/min/1.73m2 | Belatacept + MPA | Belatacept + Low-Dose Tac | Tacrolimus + MPA Standard Treatment Regimen |
|---|---|---|---|
| Change in eGFR (MDRD) at 2 Years Post-transplant Compared to Baseline at Month 3 (Conversion) | -5.44 ± 5.43 | 8.08 ± 5.74 | -0.38 ± 3.94 |
Number of Participants with Acute Rejection (AR). AR is defined as allograft dysfunctions in the setting of recipient immune system engaging an allo-response against the kidney transplant.
| Participants | Belatacept + MPA | Belatacept + Low-Dose Tac | Tacrolimus + MPA Standard Treatment Regimen |
|---|---|---|---|
| Acute Rejection | 4 | 0 | 2 |
Number of Subjects with a functioning Graft
| Participants | Belatacept + MPA | Belatacept + Low-Dose Tac | Tacrolimus + MPA Standard Treatment Regimen |
|---|---|---|---|
| Graft Survival | 8 | 8 | 10 |
Number of Subjects alive at the end of 24 months
| Participants | Belatacept + MPA | Belatacept + Low-Dose Tac | Tacrolimus + MPA Standard Treatment Regimen |
|---|---|---|---|
| Patient Survival | 9 | 7 | 9 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Belatacept + MPA | 0/9 (0%) | 0/9 (0%) | 6/9 (66.7%) |
| Belatacept + Low-Dose Tac | 1/8 (12.5%) | 1/8 (12.5%) | 7/8 (87.5%) |
| Tacrolimus + MPA Standard Treatment Regimen | 1/10 (10%) | 1/10 (10%) | 7/10 (70%) |
| Event | Belatacept + MPA | Belatacept + Low-Dose Tac | Tacrolimus + MPA Standard Treatment Regimen |
|---|---|---|---|
| DeathEndocrine disorders | 0/9 | 1/8 | 0/10 |
| Squamous Cell CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/9 | 1/8 | 0/10 |
| DeathInfections and infestations | 0/9 | 0/8 | 1/10 |
| Event | Belatacept + MPA | Belatacept + Low-Dose Tac | Tacrolimus + MPA Standard Treatment Regimen |
|---|---|---|---|
| BK infectionsInfections and infestations | 3/9 | 4/8 | 1/10 |
| NeutropeniaBlood and lymphatic system disorders | 3/9 | 3/8 | 2/10 |
| HyperlipidemiaMetabolism and nutrition disorders | 1/9 | 0/8 | 3/10 |
| CMVInfections and infestations | 1/9 | 1/8 | 1/10 |
| Age, Continuous(years) | Belatacept + MPA | Belatacept + Low-Dose Tac | Tacrolimus + MPA Standard Treatment Regimen | Total |
|---|---|---|---|---|
| Mean | 47 ± 16.21 | 49.75 ± 13.33 | 49.70 ± 13.53 | 48.81 ± 13.70 |
| Sex: Female, Male(Participants) | Belatacept + MPA | Belatacept + Low-Dose Tac | Tacrolimus + MPA Standard Treatment Regimen | Total |
|---|---|---|---|---|
| Female | 2 | 5 | 4 | 11 |
| Male | 7 | 3 | 6 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Belatacept + MPA | Belatacept + Low-Dose Tac | Tacrolimus + MPA Standard Treatment Regimen | Total |
|---|---|---|---|---|
| Hispanic or Latino | 3 | 1 | 5 | 9 |
| Not Hispanic or Latino | 1 | 1 | 1 | 3 |
| Unknown or Not Reported | 5 | 6 | 4 | 15 |
| Race (NIH/OMB)(Participants) | Belatacept + MPA | Belatacept + Low-Dose Tac | Tacrolimus + MPA Standard Treatment Regimen | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 3 | 0 | 4 |
| White | 4 | 3 | 4 | 11 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 2 | 6 | 12 |
| Region of Enrollment(participants) | Belatacept + MPA | Belatacept + Low-Dose Tac | Tacrolimus + MPA Standard Treatment Regimen | Total |
|---|---|---|---|---|
| United States | 9 | 8 | 10 | 27 |
| Incidence of Delayed Graft Function(Participants) | Belatacept + MPA | Belatacept + Low-Dose Tac | Tacrolimus + MPA Standard Treatment Regimen | Total |
|---|---|---|---|---|
| Count of participants | 0 | 0 | 1 | 1 |
| Incidence of Diabetes(Participants) | Belatacept + MPA | Belatacept + Low-Dose Tac | Tacrolimus + MPA Standard Treatment Regimen | Total |
|---|---|---|---|---|
| Count of participants | 0 | 2 | 3 | 5 |
| Incidence of Hypertension(Participants) | Belatacept + MPA | Belatacept + Low-Dose Tac | Tacrolimus + MPA Standard Treatment Regimen | Total |
|---|---|---|---|---|
| Count of participants | 8 | 6 | 10 | 24 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Jul 2014, a primary completion of Sep 2020 and a completion of Sep 2020. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2021, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Abatacept · Medroxyprogesterone Acetate
Lorenzo Gallon