Long-term Outcomes After Conversion to Belatacept

Immunosuppression Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Drug Effect Prolonged
• Graft Loss
• Immunosuppression
• Kidney Transplant Failure and Rejection

• NCT number: NCT04733131
• Study type: Observational
• Source: Paris Translational Research Center for Organ Transplantation
• Status: Active, not recruiting
• Start date: January 1, 2004
• Completion date: December 2021