Drug Effect Prolonged, Graft Loss, Immunosuppression, Kidney Transplant Failure and Rejection
Conditions
Keywords
belatacept, multicenter study, Long term outcomes
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.
Interventions
DRUGConversion to a belatacept regimen
belatacept intravenous on Days 1, 15, 29, 43, 57 then every 28 days.
Sponsors
Paris Translational Research Center for Organ Transplantation
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Patient survival after conversion to belatacept | 5 years | Patient survival after conversion to a belatacept regimen |
Outcome results
None listed