Effect of an Early Switch to Belatacept Among Calcineurin Inhibitor-Intolerant Graft Recipients of Kidneys From Extended-Criteria Donors.
Y Le Meur, F Aulagnon, D Bertrand...
https://pubmed.ncbi.nlm.nih.gov/26718625Actively Recruiting
Phase 3
Age: 18Years - 99Years
All Genders
ID05562869
Belatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction
Led by Nantes University Hospital · Updated on 2024-05-09
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment strategy for patients who have undergone kidney transplantation but experience early graft dysfunction. The study focuses on replacing the standard calcineurin inhibitors (CNI), which can cause chronic kidney damage, with belatacept, a newer drug that affects the immune response differently. This Phase 3 trial aims to test if temporarily switching from CNI to belatacept between 3 and 12 months after transplant can improve kidney function without increasing rejection risks or costs. Participants will receive belatacept through intravenous infusions initially every two weeks and then monthly from 3 to 12 months post-transplant, while stopping CNI during this period. After 12 months, belatacept treatment will stop, and low-dose CNI will be reintroduced for the following 6 months. This two-phase approach will help researchers understand if this temporary replacement is feasible and beneficial compared to continuous CNI or belatacept use. During the study, patients will have regular kidney function tests, biopsies, immune system monitoring, and assessments of treatment tolerance and quality of life up to 15 months after transplant. Researchers will track rejection episodes, viral infections, and healthcare costs. The main goal is to see if kidney function remains stable after switching back to CNI. This detailed follow-up will help determine the practicality and economic impact of this new treatment approach.
CONDITIONS
Brief Title
Belatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction
Who Can Participate
Age: 18Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adult older than 18 years old
- Kidney transplant from a deceased or living donor with compatible blood type
- No contraindication to graft biopsy 10 weeks post transplant
- Currently treated with calcineurin inhibitor and mycophenolic acid or mycophenolate mofetil, with or without prednisone
- Kidney function estimated by creatinine clearance less than 30 ml/min/1.73 m2
- Able to understand and communicate with the investigator
- Willing to give informed written consent
- Covered by Social Security
- Kidney biopsy at 10 weeks post-transplant shows no rejection, BK virus nephropathy, recurrence, thrombotic microangiopathy, or cortical necrosis
- Positive for Epstein-Barr virus (EBV)
- Negative pregnancy test and agreement to use effective contraception during the study
You will not qualify if you...
- Presence of donor specific antibodies during transplant or at 3 months post-transplant
- Positive for HIV
- History of other solid organ transplants besides kidney
- Primary non-function requiring dialysis at 3 months post-transplant
- Participating in another interventional clinical study
- Any clinical condition considered incompatible with the study by the investigator
- Contraindication to belatacept or tacrolimus
- Pregnant or breastfeeding women
- Unable to comply with study procedures
- Under legal guardianship, curatorship, or safeguard of justice
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 9 months
Participants receive belatacept treatment by intravenous infusion from 3 to 12 months post-transplantation, replacing calcineurin inhibitors (CNI) during this period.
Monthly visits for belatacept infusions
Treatment
Duration - 6 months
From 12 to 18 months post-transplantation, belatacept treatment is stopped and CNI treatment is reintroduced with tacrolimus targeting 6 ng/ml.
Regular visits for monitoring during CNI reintroduction
Trial Site Locations
Total: 1 location
1
CHU Nantes
Nantes, Loire Atlantique, France, 44093
Actively Recruiting
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Research Team
S
Simon VILLE, PH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Belatacept and Long-Term Outcomes in Kidney Transplantation.
Flavio Vincenti
https://pubmed.ncbi.nlm.nih.gov/27355541