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Study identifier: NCT04180085 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Heart Transplant Failure  ·  Sponsor: Nantes University Hospital

PhasePhase 2
Planned participants25
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Claire GARANDEAU, PH  ·  0240087453  ·  claire.garandeau@chu-nantes.fr

Always discuss trial participation with your own doctor first.

Locations (4)

Karine NubretBordeaux, FranceRecruiting
Laurent SebbagLyon, FranceRecruiting
Claire GarandeauNantes, FranceRecruiting
Bertrand LelongRennes, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT04180085