Status:
UNKNOWN
CNI Transient Replacement by Belatacept From 3 to 12 Months Post Transplantation in Patients With Early Graft Dysfunction
Lead Sponsor:
Nantes University Hospital
Conditions:
Chronic Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 dys...
Detailed Description
The standard maintenance regimen in renal transplantation combines calcineurin inhibitor (CNI: ciclosporin or tacrolimus) and anti-metabolite drugs (mycophenolate mofetil (MMF) or mycophenolic acid (M...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 9 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04013620
Start Date
September 1 2020
End Date
July 9 2022
Last Update
March 31 2020
Active Locations (1)
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1
CHU de Nantes
Nantes, France, 44000