Imagine receiving a kidney transplant and having a better chance at a successful recovery. This study is enrolling 800 adult first-time kidney transplant recipients to evaluate a new biomarker, the HLA-DR/DQ molecular mismatch score. This score could help doctors predict the risk of complications after the transplant. After six months, 300 eligible participants will be randomly assigned to either receive abatacept, a new treatment, or standard care. The goal is to see if switching from Tacrolimus, a common medication, to abatacept can improve kidney function and overall quality of life while still preventing rejection of the new kidney. This research is crucial because it could lead to better outcomes for patients, helping them enjoy a healthier life after transplant.
Could a new biomarker improve kidney transplant outcomes for patients?
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What this means for you:
A new biomarker might help improve kidney transplant outcomes and patient quality of life. What this means for you:
A new biomarker might help improve kidney transplant outcomes and patient quality of life. View Original Abstract ↓
Status: RECRUITING | Phase: PHASE2
Condition(s): Kidney Transplant
Intervention(s): Abatacept (BIOLOGICAL), Standard of Care at US Transplant Centers (PROCEDURE)
800 adult first time kidney transplant recipients will be enrolled in the Observational Study and followed to evaluate their Human Leukocyte Antigen (HLA)-DR/DQ molecular mismatch (mMM) score as a risk-stratifying prognostic biomarker. Six months after transplant the study will identify those who meet the eligibility criteria for the Nested Randomized Control Trial (RCT). 300 eligible subjects will be randomized 2:1 to abatacept or Standard of care (SOC) in the randomization and followed for 18 months monitoring for safety and improvement in renal function, neurocognitive function, and a life participation patient reported outcome measure (PROM).
The primary objective of the Observational Study is to test the validity of the HLA-DR/DQ mMM score as a prognostic biomarker for stratification of post-transplant alloimmune risk. Whereas the objective of the Nested RCT is to test whether a superior outcome in kidney function (primary endpoint), as well as secondary endpoints (neurocognitive function, and life participation PROM), will be achieved in patients who are transitioned from Tacrolimus (TAC) to abatacept, while maintaining efficacy (freedom from biopsy proven acute rejection).
Detailed: Observational Study:
Enrolling 800 adult first time kidney transplant recipients. Consent and enrollment will be targeted to occur pre- or post-kidney transplant during the initial hospitalization. All subjects enrolled in the study will be followed observationally to evaluate HLA-DR/DQ molecular mismatched (mMM) as a risk-stratifying prognostic biomarker.
This prospective, multi-center, observational study of 800 kidney transplant recipients at clinically low risk for alloimmune memory (DSA negative pre-kidney transplant) who are initiated on standard of care (SOC) therapy will be used to satisfy the FDA requirement to prospectively evaluate the HLA mMM score as a prognostic biomarker for post-kidney transplant outcomes in a real-world cohort. Donor-recipient HLA-DR/DQ mMM score will be
Primary Outcome(s): In the Observational Study - The occurrence of any alloimmune event; 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).
Enrollment: 800 (ESTIMATED)
Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start: 2023-12-07 | Primary Completion: 2027-07