RecruitingPhase 3NCT05562869

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


Sponsor

Nantes University Hospital

Enrollment

30 participants

Start Date

May 3, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether switching kidney transplant patients from their current anti-rejection medication (calcineurin inhibitors, or CNIs) to a different drug called belatacept can help protect the kidney and improve long-term outcomes. This switch is targeted at patients whose transplanted kidney isn't functioning very well early on after transplant. **You may be eligible if...** - You are an adult (18+) who received a kidney transplant from a living or deceased donor - Your kidney function 3 to 12 months after transplant is poor (creatinine clearance under 30 mL/min) - A biopsy taken 10 weeks after transplant showed no rejection, no viral infection, no recurrence of original disease, and no clotting problems - You tested positive for the Epstein-Barr virus (EBV) before transplant - You are not HIV positive - You used a negative pregnancy test and agree to use effective contraception **You may NOT be eligible if...** - You developed donor-specific antibodies during or 3 months after the transplant - You are HIV positive - You have had another solid organ transplant - Your transplanted kidney never functioned and you are still on dialysis at 3 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBelatacept 250 Milligram Intravenous Powder for Solution

Phase 1 (from 3 to 12 months post transplantation): conversion to belatacept (IV, 5mg/Kg days 1, 15,30, 45, 60 then every months) and CNI withdrawal. Phase 2 (from 12 to 18 months post transplantation) : belatacept arrest and CNI resumption (tacrolimus target 6 ng/ml)


Locations(1)

CHU Nantes

Nantes, Loire Atlantique, France

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NCT05562869


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