Using belatacept instead of CNIs for kidney transplant patients with early graft dysfunction
Belatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction
This study is testing if belatacept can safely replace standard medications for kidney transplant patients who are having early problems with their new kidney.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Nantes, Loire Atlantique) |
| Trial ID | NCT05562869 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of belatacept, a fusion protein that blocks CD28 costimulation, as a replacement for calcineurin inhibitors (CNI) in patients experiencing early graft dysfunction after kidney transplantation. The study aims to evaluate the safety and efficacy of belatacept administered 3 to 12 months post-transplantation, focusing on improving renal function and reducing chronic graft dysfunction associated with CNI nephrotoxicity. Participants will receive belatacept intravenously, and their renal function will be monitored through creatinine clearance assessments. The trial seeks to provide a viable alternative to standard CNI therapy, which has been linked to long-term graft failure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have undergone kidney transplantation and are experiencing early graft dysfunction.
Not a fit: Patients who have contraindications to graft biopsy or those with specific donor-specific antibodies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved kidney transplant outcomes and better long-term graft survival for patients with early graft dysfunction.
How similar studies have performed: Previous studies have shown promising results with belatacept in kidney transplantation, but this specific approach for early graft dysfunction is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nantes, Loire Atlantique
- CHU Nantes — Nantes, Loire Atlantique, France (Recruiting)
Study contacts
- Study coordinator: Simon VILLE, PH
- Email: simon.ville@chu-nantes.fr
- Phone: 0240087453
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.