Long-term Outcomes After Conversion to Belatacept

• Conditions: Kidney Transplant Failure and Rejection; Drug Effect Prolonged; Immunosuppression; Graft Loss
• Interventions: Drug: Conversion to a belatacept regimen

• Registration Number: NCT04733131
• Lead Sponsor: Paris Translational Research Center for Organ Transplantation

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-01-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-29
• Last Update Submitted: 2021-01-29
• Study First Posted: 2021-02-01
• Last Update Posted: 2021-02-01
• Primary Completion: 2021-06
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 324

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
converted to a belatacept based immunosuppression	Conversion to a belatacept regimen	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.

Primary Outcome Measures

Name	Time	Method
Patient survival after conversion to belatacept	5 years	Patient survival after conversion to a belatacept regimen
Allograft survival after conversion to belatacept	5 years	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.