NCT04180085

Pilot Study: Interest of Belatacept as a Non-nephrotoxic Immunosuppressive Treatment in Cardiac Transplant Patients at Risk of Chronic Renal Failure (BELACOEUR)

Pilot Study: Interest of Belatacept as a Non-nephrotoxic Immunosuppressive Treatment in Cardiac Transplant Patients at Risk of Chronic Renal Failure

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Heart transplantation (TC) is the standard treatment for terminal heart failure. Chronic kidney disease (CKD) is a common complication responsible for increased mortality and morbidity. The main risk factors for progression to CKD are advanced age, pre-transplantation CKD, degradation of glomerular filtration rate (GFR) in the first year post-transplantation, and nephrotoxicity of calcineurin inhibitors (CNI). Indeed, these molecules (cyclosporin and tacrolimus), the cornerstone of immunosuppressive treatment, have nephrotoxic effects in the short term (by a hemodynamic effect) and in the long term (by a pro-fibrosin effect). In renal transplantation (TR), belatacept, a costimulation-inhibiting molecule, used de novo, without CNI, with induction by anti-receptor antibody of Interleukines 2, preserves kidney function. Despite this great advantage, its development is still hampered by a higher number of rejections compared to the CNI group in this originator study. Based on the experience gained in TR, which has since validated its use, the hypothesis is that in heart transplantation, belatacept (Nulojix) combined with minimization of CNI (with induction by antilymphocyte serum), could significantly improve glomerular filtration rate (GFR) in patients at risk of CKD (by removing them from dialysis and possible kidney transplantation) without increasing the risk of rejection.

Conditions

• Heart Transplant Failure

Interventions

Type	Name	Description
DRUG	Belatacept Injection	9 injections of belatacept at 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months 11 months and 12 months post graft

Timeline

• Start date: 2020-02-06
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2019-11-27
• Last updated: 2026-01-15

Locations

4 sites across 1 country: France