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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    25
  • sponsor
    Nantes University Hospital
Updated on 2 May 2021

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.

Details
Condition Heart Transplant Failure
Treatment Belatacept Injection
Clinical Study IdentifierNCT04180085
SponsorNantes University Hospital
Last Modified on2 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Cardiac transplant patients for 3 months Over 18 years of age No Donor
Specific Antibodies at inclusion (positive threshold average fluorescence
intensity (MFI)> 2000) Having a GFR (DFG in french) is the single best
indicator of overall renal function < 30ml/min calculated according to the
formula CKD EPI or a decrease in GFR of more than 50% between the day of the
heart transplant and 3 months, stable for 15 days
Induction treatment with anti-lymphocyte serum Virus d'Epstein-Barr positive
serology Having signed the consent after receiving informed information
Negative pregnancy test for patients of childbearing age, and agreement to use
effective contraception throughout the study and 6 weeks after the end of the
study Having no difficulty in understanding and communicating with the
investigator and his representatives Beneficiaries of a Social Security scheme

Exclusion Criteria

The criteria for non-inclusion are
nd heart transplant or other solid organ transplant History of rejections
Cellular or humoral rejection at myocardial biopsy of 3 months post
Transplantation Cardiac Current viral infection of type cytomegalovirus, Virus
d'Epstein-Barr, hepatitis C virus, hepatitis V virus
Human immunodeficiency virus positive serology Ongoing participation in
another clinical study Any clinical condition that the investigator considers
incompatible with the conduct of the study under acceptable safety conditions
(in particular, progressive infection, progressive cardiovascular
complication, progressive neoplastic disease) Inability of the patient to
comply with study procedures Pregnant or breastfeeding women Person under
guardianship, curators or safeguard of justice
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