Biomarker-Guided CNI Substitution In Kidney Transplantation
This study is for adults aged 18 to 70 who are receiving their first kidney transplant. It aims to see if a biomarker (a biological indicator) called HLA-DR/DQ molecular mismatch (mMM) can predict how well a kidney transplant will do. Initially, 800 participants will be observed for 6 months. After this, 300 eligible participants will be randomly assigned to either continue their standard care (Tacrolimus, Mycophenolic Acid (MPA), and Prednisone) or switch to a different medication called Abatacept. Researchers will then compare how well their kidneys are working and look at other health outcomes over 18 months.
- Study design
- This is an interventional study with an initial observational phase enrolling 800 participants, followed by a nested randomized control trial involving 300 participants. Participants will be randomly assigned to receive either Abatacept or standard care.
- What's involved
- Participants will be followed for up to 24 months post-transplant in the observational study, and for 18 months post-randomization in the nested trial. This will involve monitoring for alloimmune events and assessing kidney function.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in the observational study will be followed for up to 24 months post-transplant. Those in the nested randomized control trial will be followed for 18 months after randomization.
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Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation
At a glance
Conditions
Where it's being run
15 sites across 13 statesStudy leadership
- Peter S Heeger, M.D. · STUDY_CHAIR · Cedars Sinai Medical Center: Transplantation
- Peter Nickerson, M.D. · STUDY_CHAIR · University of Manitoba Max Rady College of Medicine - Transplantation
Who to contact
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What this trial measures
- In the Observational Study - The occurrence of any alloimmune eventUp to 24 months post-Kidney Transplant
including de novo Donor Specific Antibody (DSA), any Biopsy Proven Acute Rejection (BPAR) (Banff borderline or greater, on a for-cause or the 6-month post-transplant protocol biopsy) and censored by non-alloimmune graft failure or death with function or lost-to-follow up.
- In the Nested Randomized Control Trial (RCT) - Renal function, measured as the difference in eGFRCKD-EPI at 24-months between groups (adjusted for renal function at randomization).At 18 months post-randomization (24 months post-transplant)