Long-term Outcomes After Conversion to Belatacept

Paris Translational Research Center for Organ Transplantation

Status: Unknown

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

Treatments: Drug: Conversion to a belatacept regimen

Study type: Observational

Funder types: Other

Identifiers

NCT04733131

switch_bela2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 324 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

324 participants in 1 patient group

converted to a belatacept based immunosuppression

Description:

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.

Treatment:

Drug: Conversion to a belatacept regimen