A Phase 4 interventional study of Belatacept and Tacrolimus in Implant or Graft; Rejection, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-10.
Sponsored by Columbia University · Phase 4, Interventional, and Treatment
The main purpose of this study is to find out whether treatment to prevent kidney rejection with belatacept in presence of Thymoglobulin induction and withdrawal of steroids will result in less delayed graft function or "sleepy kidney" after transplant than that seen in patients who get tacrolimus as their main drug to prevent rejection instead of belatacept. The investigators will also look at whether patients who get belatacept have the same, lesser or more problems that those who get tacrolimus.
New York Presbyterian Hospital-Columbia University Medical Center (NYPH-CUMC) performs nearly 250 renal transplants annually; of these approximately half are recipients of a variety of deceased donor kidneys, usually with cold ischemia time (CIT) >24 hours leading to an approximate incidence of delayed graft function (DGF) of 50%. The main focus of this study will be to determine whether initial immunosuppression with belatacept with Thymoglobulin induction will result in lower incidence and/or more rapid disappearance of DGF than that observed in patients who receive tacrolimus based immunosuppression. NGAL determinations will bne made in the first months after transplantation to correlate with clinical DGF.
83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.
This study's enrollment of 57 is below the median of 90 across 62 interventional studies indexed under Delayed Graft Function.
Browse Delayed Graft Function studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
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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.
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.
The human immunodeficiency virus, which weakens the immune system.
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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.
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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.
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.
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.
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.
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.
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.
Renal transplant recipients will receive steroids (Methylprednisolone), rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.
Drug: Belatacept · Drug: Mycophenolate · Drug: rATG · Drug: Methylprednisolone · Procedure: Renal transplant
Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.
Drug: Tacrolimus · Drug: Mycophenolate · Drug: rATG · Drug: Methylprednisolone · Procedure: Renal transplant
Belatacept 10 mg/kg will be administered in the operating room approximately 1 hour prior to kidney allograft reperfusion (Day 0). It will then be administered at 10 mg/kg on the following post-transplantation days: Day 5, 14, 30, 56, and 84. Belatacept 5 mg/kg will be administered every four weeks thereafter until end of study.
Also known as: Nulojix
Tacrolimus 0.05 mg/kg by mouth every 12 hours will be on Day 0 after transplantation. It will then be administered at 8-12 ng/mL on the following post-transplantation days: Day 3-90; at 8-10 ng/mL Day 91-180. Tacrolimus 6 - 8 ng/mL will be administered daily thereafter until end of study. (standard of care)
Also known as: Prograf
An immunosuppressive agent used with other medicines to lower the body's natural immunity in patients who receive kidney transplants. 720 mg by mouth every 12 hours (Day 0)(1080 mg AA). (standard of care)
Also known as: Myfortic
1.5 mg/kg IV daily on Day 0-3. (standard of care)
Also known as: induction with rabbit anti-thymocyte globulin
500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered from Day 0-3. (standard of care)
Also known as: Medrol
Standard organ transplant of a kidney into a patient with end-stage renal disease.
Also known as: Kidney transplant
Number of Participants With Delayed Graft Function (DGF)
To assess whether treatment with Thymoglobulin induction and belatacept based maintenance immunosuppression would reduce delayed graft function (DGF) rates among recipients of deceased donor renal transplants as measured by clinical findings and NGAL marker, as specified below and defined by others. This will be compared to the incidence of DGF in patients treated with a Tacrolimus based regimen. Patients who require hemodialysis in the first 7 days after transplantation and/or patients whose serum creatinine decreases \<10% during 3 consecutive days after the transplant will be considered to have DGF in the absence of other confounding factors such as obstruction or infection. NGAL will be used as a verification marker of DGF.
Time frame: Up to 3 months post-transplantation
Percentage of Participants With Allograft Survival
Allograft survival is defined as functioning renal transplant.
Time frame: Up to 1 year post-transplantation
Number of Participants With an Allograft Rejection Episode
All rejection episodes will be confirmed by renal transplant biopsy provoked by change in renal function not explained by other clinical causes.
Time frame: Up to 1 year post-transplantation
Estimated Glomerular Filtration Rate (eGFR)
Estimated glomerular filtration rate (eGFR) is based on a blood sample (serum creatinine value), age, race, and gender. eGFR estimates best the function of the kidney at any one time.
Time frame: Up to 1 year post-transplantation
| Milestone | Belatacept Immunosuppression | Standard Immunosuppression (Tacrolimus) |
|---|---|---|
| Started | 28 | 29 |
| Completed | 24 | 24 |
| Not completed | 4 | 5 |
| Withdrew: Case cancellations | 2 | 4 |
| Withdrew: Withdrawal by subject | 2 | 1 |
To assess whether treatment with Thymoglobulin induction and belatacept based maintenance immunosuppression would reduce delayed graft function (DGF) rates among recipients of deceased donor renal transplants as measured by clinical findings and NGAL marker, as specified below and defined by others. This will be compared to the incidence of DGF in patients treated with a Tacrolimus based regimen. Patients who require hemodialysis in the first 7 days after transplantation and/or patients whose serum creatinine decreases \<10% during 3 consecutive days after the transplant will be considered to have DGF in the absence of other confounding factors such as obstruction or infection. NGAL will be used as a verification marker of DGF.
| Participants | Belatacept Immunosuppression | Standard Immunosuppression (Tacrolimus) |
|---|---|---|
| Number of Participants With Delayed Graft Function (DGF) | 12 | 15 |
Allograft survival is defined as functioning renal transplant.
| Participants | Belatacept Immunosuppression | Standard Immunosuppression (Tacrolimus) |
|---|---|---|
| Percentage of Participants With Allograft Survival | 24 | 21 |
All rejection episodes will be confirmed by renal transplant biopsy provoked by change in renal function not explained by other clinical causes.
| Participants | Belatacept Immunosuppression | Standard Immunosuppression (Tacrolimus) |
|---|---|---|
| Number of Participants With an Allograft Rejection Episode | 7 | 11 |
Estimated glomerular filtration rate (eGFR) is based on a blood sample (serum creatinine value), age, race, and gender. eGFR estimates best the function of the kidney at any one time.
| mL/min/1.73m^2 | Belatacept Immunosuppression | Standard Immunosuppression (Tacrolimus) |
|---|---|---|
| Estimated Glomerular Filtration Rate (eGFR) | 46 ± 15.85 | 41 ± 11.45 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Belatacept Immunosuppression | 4/24 (16.7%) | 14/24 (58.3%) | 5/24 (20.8%) |
| Standard Immunosuppression (Tacrolimus) | 1/24 (4.2%) | 15/24 (62.5%) | 3/24 (12.5%) |
| Event | Belatacept Immunosuppression | Standard Immunosuppression (Tacrolimus) |
|---|---|---|
| Delayed Graft FunctionRenal and urinary disorders | 12/24 | 15/24 |
| RejectionRenal and urinary disorders | 7/24 | 11/24 |
| CMV quant+Infections and infestations | 9/24 | 5/24 |
| BK quant+Infections and infestations | 6/24 | 3/24 |
| EBV quant+Infections and infestations | 3/24 | 3/24 |
| Posttransplant lymphoproliferative diseaseRenal and urinary disorders | 0/24 | 1/24 |
| Event | Belatacept Immunosuppression | Standard Immunosuppression (Tacrolimus) |
|---|---|---|
| BleedingBlood and lymphatic system disorders | 5/24 | 3/24 |
| AnemiaBlood and lymphatic system disorders | 3/24 | 2/24 |
| Urinary Tract InfectionRenal and urinary disorders | 3/24 | 1/24 |
| Age, Categorical(Participants) | Belatacept Immunosuppression | Standard Immunosuppression (Tacrolimus) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 25 | 46 |
| >=65 years | 7 | 4 | 11 |
| Age, Continuous(years) | Belatacept Immunosuppression | Standard Immunosuppression (Tacrolimus) | Total |
|---|---|---|---|
| Mean | 57.4 (42 to 77) | 53.8 (23 to 67) | 55.6 (23 to 77) |
| Sex: Female, Male(Participants) | Belatacept Immunosuppression | Standard Immunosuppression (Tacrolimus) | Total |
|---|---|---|---|
| Female | 14 | 25 | 39 |
| Male | 14 | 4 | 18 |
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jun 2014, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2019, 2 years 8 months after primary completion.
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Abatacept