🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Belatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction

RecruitingPhase 3Ages 18 Years - 99 YearsAllNantes University Hospital
NCT05562869 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

Calcineurin inhibitors (CNI) remain the standard treatment in renal transplantation to prevent rejection. Currently the main limitation of kidney transplantation is the occurrence of chronic graft dysfunction due to the CNI nephrotoxicity. Thus, strategies to minimize or stop CNI have been developed as belatacept, a fusion protein (CTLA4-Ig) blocking the ligand of the main CD28 costimulatory molecule. In the original phase III trial, used de novo in combination with MMF (without CNI) belatacept allowed to obtain a better renal function as soon as 1 year and a better graft and patient survival after 7 years. Despite these excellent results, belatacept has not become the gold standard due to a higher incidence of early rejection. In addition, belatacept is not covered by the french social security policy, because benefits are considered insufficient with respect to the cost. Patients with

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
Inclusion Criteria: * adult older than 18 years old. * transplantation of a deceased or living donor kidney (non-human leukocyte antigen(HLA)-identical) with blood type (ABO) compatibility * no contraindication to the protocol graft biopsy (10 weeks post transplant) * treatment by CNI / MPA +/- prednisone * renal function estimated by creatinine clearance according to CKD-EPI \<30 ml / min / 1.73m2. * having no difficulty in understanding and communicating with the investigator and his representatives. * Agreeing to give informed written consent * benefiting from a Social Security policy. * results of the 10-week post-transplant renal biopsy finding no rejection or BK virus (member of the polyomavirus family) nephropathy, no recurrence, no thrombotic microangiopathy, no cortical necrosis. * Seropositivity for Epstein-Barr virus (EBV) * negative pregnancy test and agreement on the use of effective contraception throughout the study Exclusion Criteria: * Presence of Donor Specific Antibody during kidney transplant or appeared at 3 months post-transplantation. * seropositivity for HIV * another history of other solid organ transplants (outside the kidney) * primary non-function (persistence of a need for dialysis at 3 months post-transplantation) * participation in progress to another interventional clinical study * any clinical condition that the investigator considers incompatible with the course of the study. * contraindication to belatacept and Tacrolimus * Pregnant or breastfeeding woman * Inability of the patient to comply with study procedures * Person placed under guardianship or curatorship, under safeguard of justice
💊

What it tests

  • Belatacept 250 Milligram Intravenous Powder for Solution
📍

Where

1 site
CHU Nantes
Nantes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy