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

NCT04180085 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-06
Primary Completion
2028-01-01
Completion
2028-01-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04180085 on ClinicalTrials.gov