Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation
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 c
| Condition(s) | Kidney Transplant |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: Observational Study: 1. Subject must be able to understand and provide informed consent 2. Received (within 14 days) or candidate for an ABO-compatible kidney transplant, including A2 to B 3. Panel Reactive Antibody \<=60% as determined by local site 4. Virtual cross-match negative as determined by local site or Donor Specific Antibody (DSA) negative by central lab within 14 days post-transplant 5. Female subjects of childbearing potential must have a negative pregnancy test upon study entry 6. All subjects with reproductive potential must agree to use highly effective contraception for the duration of the study (http://www.fda.gov/birthcontrol) 7. Hepatitis C Virus Ab positive subjects with negative Hepatitis C Virus polymerase chain reaction (HCV PCR) are eligible if |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Locations | Birmingham, Alabama, United States; Los Angeles, California, United States; Los Angeles, California, United States; New Haven, Connecticut, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States (+9 more sites) |
| Start date | 2023-12-07 |
| NCT ID | NCT05917522 |
| Official listing | https://clinicaltrials.gov/study/NCT05917522 |