Using Belatacept to Improve Kidney Function in Heart Transplant Patients

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

This study is testing if a new medication called belatacept can help protect kidney function in heart transplant patients who are at risk of kidney problems.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nantes University Hospital (Academic / other)
• Locations: 4 sites (Bordeaux and 3 other locations)
• Trial ID: NCT04180085 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the use of belatacept, a non-nephrotoxic immunosuppressive treatment, in heart transplant patients who are at risk of chronic renal failure. The study aims to determine if belatacept can preserve kidney function compared to traditional calcineurin inhibitors, which are known to have nephrotoxic effects. Eligible participants include cardiac transplant patients who have been transplanted for at least three months and exhibit specific renal function criteria. The study will monitor the outcomes related to kidney function and transplant rejection rates.

Who should consider this trial

Good fit: Ideal candidates are heart transplant patients over 18 years old with specific renal function impairments.

Not a fit: Patients who have undergone a second heart transplant or other solid organ transplants may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve kidney function and reduce complications in heart transplant patients.

How similar studies have performed: Previous studies have shown that belatacept can preserve kidney function in renal transplant patients, but its application in heart transplant patients is still being explored.

Eligibility criteria

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:

2nd 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

Where this trial is running

Bordeaux and 3 other locations

• Karine Nubret — Bordeaux, France (Recruiting)
• Laurent Sebbag — Lyon, France (Recruiting)
• Claire Garandeau — Nantes, France (Recruiting)
• Bertrand Lelong — Rennes, France (Recruiting)

Study contacts

• Study coordinator: Claire GARANDEAU, PH

Conditions Heart Transplant Failure