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

Launched by NANTES UNIVERSITY HOSPITAL · Sep 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called belatacept, which may help improve kidney function in patients who have undergone a kidney transplant but are experiencing early graft dysfunction. Typically, after a transplant, patients receive calcineurin inhibitors (CNI) to prevent their body from rejecting the new kidney. However, these medications can sometimes cause damage to the kidney over time. The trial aims to see if using belatacept instead of CNI for a limited time (from 3 to 12 months after transplantation) can provide benefits without increasing the risk of rejection.

To participate in the trial, individuals must be adults over 18 years old who have received a compatible kidney transplant and are experiencing poor kidney function. They should have no signs of rejection or other serious complications after 10 weeks post-transplant. Participants can expect to be closely monitored during the trial and will need to provide informed consent. It’s also important to note that this treatment is not currently covered by French social security, so participants should be aware of the financial implications.

Gender

ALL

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