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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    25
  • sponsor
    Nantes University Hospital
Updated on 13 April 2022

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 on13 April 2022

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

nd heart transplant or other solid organ transplant History of rejections Cellular or
The criteria for non-inclusion are
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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