RecruitingPhase 2NCT04180085

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


Sponsor

Nantes University Hospital

Enrollment

25 participants

Start Date

Feb 6, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether switching heart transplant patients who are developing kidney problems from their current anti-rejection drug (calcineurin inhibitor) to a less kidney-toxic alternative called belatacept can protect their kidneys and improve long-term outcomes. **You may be eligible if...** - You received a heart transplant at least 3 months ago - You are over 18 - You have significantly reduced kidney function (eGFR below 30 mL/min) or a 50%+ decline in kidney function since transplant - You do not have certain antibodies (donor-specific antibodies) that could increase rejection risk **You may NOT be eligible if...** - You have donor-specific antibodies - You are EBV-negative (a virus status that increases lymphoma risk with belatacept) - You have active serious infections (e.g., CMV disease, hepatitis) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBelatacept 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


Locations(4)

Karine Nubret

Bordeaux, France

Laurent Sebbag

Lyon, France

Claire Garandeau

Nantes, France

Bertrand Lelong

Rennes, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04180085


Related Trials