Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation (NCT05917522)
Assessment of Biomarker-Guided Calcineurin Inhibitor (CNI) Substitution In Kidney Transplantation (RTB-015)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (24 items) and avoid the listed exclusions (30 items).
Location: University of Alabama School of Medicine: Transplantation — Birmingham, Alabama
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Observational Study:
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol including a mandated 6-mo kidney transplant biopsy
- Non-Kidney Transplant (KTx) (pre-existing or concurrent)
- Current use of immunomodulatory agents (including but not limited to: Rituximab, anti-Tumor necrosis factor(TNF) Monoclonal antibodies (mAb), or Belatacept, abatacept, Janus kinase inhibitors)
- Transplant in which the kidney donor is the recipient's Identical twin
- Epstein-Barr virus (EBV) sero-negative KTx recipient
- Chronic obstructive pulmonary disease (COPD)
- Untreated Latent Tuberculosis (TB)
- Human immunodeficiency virus (HIV) infection
- Active Hepatitis B infection (HBsAg+ or anti-HBcore +)
- Enrollment in another investigational trial
- Current, diagnosed, mental illness or current, diagnosed or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (15 Sites)
- University of Alabama School of Medicine: Transplantation — Birmingham, Alabama
- Cedars Sinai Medical Center: Transplantation — Los Angeles, California
- Ronald Reagan UCLA Medical Center: Transplantation — Los Angeles, California
- Yale University, School of Medicine: Transplantation — New Haven, Connecticut
- Johns Hopkins Hospital:Transplantation — Baltimore, Maryland
- Massachusetts General Hospital: Transplantation — Boston, Massachusetts
- Mayo Clinic Rochester: Transplantation — Rochester, Minnesota
- Washington University School of Medicine in St. Louis — St Louis, Missouri
- University of Nebraska Medical Center: Transplantation — Omaha, Nebraska
- Duke University Medical Center: Transplantation — Durham, North Carolina
- Cleveland Clinic Foundation: Transplantation — Cleveland, Ohio
- University of Pennsylvania Medical Center: Transplantation — Philadelphia, Pennsylvania
- University of Pittsburgh Medical Center: Transplantation — Pittsburgh, Pennsylvania
- University of Virginia Health System: Transplantation — Charlottesville, Virginia
- University of Wisconsin School of Medicine and Public Health: Transplantation — Madison, Wisconsin
📞 Contact the Study Coordinator
Phone: (205) 934-4011
Email: acharbin@uabmc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Social Support Counseling Intervention for Kidney Transplant Candidates — Minneapolis, Minnesota
- Empagliflozin Treatment in Kidney Transplant Recipients — Hines, Illinois
- Phenotype Guided Vasoactive Medication During Kidney Transplantation — Los Angeles, California
Explore by condition: All Kidney Transplant clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.