Using Belatacept to Improve Kidney Function in Heart Transplant Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: claire.garandeau@chu-nantes.fr
• Phone: 0240087453

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.