NCT05562869 Belatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction
| NCT ID | NCT05562869 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Nantes University Hospital |
| Condition | Chronic Kidney Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-05-03 |
| Primary Completion | 2027-05-03 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 30 participants in total. It began in 2024-05-03 with a primary completion date of 2027-05-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 poor early graft function are a preferred indication of belatacept. It is then used instead of CNI at 3 months post-transplant allowing to improve kidney function without over-risk of rejection. Currently after conversion, belatacept is maintained indefinitely due to the supposed CNI chronic nephrotoxicity. However this one is more and more questionable. Thus, the investigators assume that in patients with poor function at 3 months posttransplantation the belatacept's benefit could be obtained by a transient replacement of CNI by belatacept from 3 to 12 months post-transplantation. It is the feasibility of this strategy and its medico-economic impact that the investigators wish to study.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05562869 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Chronic Kidney Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05562869 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 30 participants.
Is NCT05562869 currently recruiting?
Yes, NCT05562869 is actively recruiting participants. Contact the research team at simon.ville@chu-nantes.fr for enrollment information.
Where is the NCT05562869 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT05562869 clinical trial?
NCT05562869 is sponsored by Nantes University Hospital. The trial plans to enroll 30 participants.
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