Long-term Outcomes After Conversion to Belatacept

Study Overview
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Brief Summary
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belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant have not been yet reported.

Detailed Description
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belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Major studies evaluating belatacept showed that de novo kidney transplant patients treated with belatacept presented an improved renal function with a higher average estimated glomerular filtration rate (eGFR) compared to ciclosporin (CsA) regimen in patients. Conversion to belatacept after transplant seems to be safe even in highly sensitized patients. However, long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant and compared to a matched control group under a CNIs regimen have not been yet reported. A multicenter cohort of kidney transplant patients, will be use to match patients converted to a belatacept immunosuppressive regimen to a control group under CNIs immunosuppressive regimen.

Official Title
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Long-term Outcomes After Conversion to a Belatacept-based Immunosuppression in Kidney Transplant

Conditions
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Kidney Transplant Failure and Rejection, Immunosuppression, Graft Loss, Drug Effect Prolonged

Intervention / Treatment
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* Drug: Conversion to a belatacept regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female, over 18 years of age Recipient of kidney allograft from a living donor or a deceased donor Exclusion Criteria: Graft loss during the first three months post-transplant Epstein-Barr virus Seronegative in the belatacept group

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| converted to a belatacept based immunosuppression<br>Belatacept: infusion on Days 1, 15, 29, 43, 57 then every 28 days. All patients received a background maintenance immunosuppressive regimen of mycophenolate mofetil or mycophenolic acid, with adjunctive corticosteroids, according to their immunosuppressive regimen at the time of enrollment. | Drug: Conversion to a belatacept regimen<br>* belatacept intravenous on Days 1, 15, 29, 43, 57 then every 28 days.<br>* Other names: Nulojix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allograft survival after conversion to belatacept | Graft loss is defined as either functional loss or physical loss (nephrectomy). Functional loss is defined as an eGFR< 15 ml/min/1.73m2 or consecutive days of dialysis. For patients who died with a functioning graft, graft survival will be censored at the time of death as a survived or functional graft. | 5 years | 
| Patient survival after conversion to belatacept | Patient survival after conversion to a belatacept regimen | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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belatacept, multicenter study, Long term outcomes