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Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation
NCT05917522 · View on ClinicalTrials.gov ↗
Study 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 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).
Conditions Studied
Interventions
- BIOLOGICAL Abatacept
- PROCEDURE Standard of Care at US Transplant Centers
Study Locations (15)
California
- Cedars Sinai Medical Center: Transplantation — Los Angeles
- Ronald Reagan UCLA Medical Center: Transplantation — Los Angeles
Pennsylvania
- University of Pennsylvania Medical Center: Transplantation — Philadelphia
- University of Pittsburgh Medical Center: Transplantation — Pittsburgh
Alabama
- University of Alabama School of Medicine: Transplantation — Birmingham
Connecticut
- Yale University, School of Medicine: Transplantation — New Haven
Maryland
- Johns Hopkins Hospital:Transplantation — Baltimore
Massachusetts
- Massachusetts General Hospital: Transplantation — Boston
Minnesota
- Mayo Clinic Rochester: Transplantation — Rochester
Missouri
- Washington University School of Medicine in St. Louis — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2023-12-07 |
| Est. Completion | 2029-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05917522
The ClinicalTrials.gov registry entry for NCT05917522 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Kidney Transplant appearing as the primary indexed condition, and to 2 interventions — of which Abatacept is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05917522 reports 15 study locations spanning 13 distinct geographic areas — top geographies include California, Pennsylvania, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05917522 about?
NCT05917522 is a clinical study titled "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 me...
What is the current status of trial NCT05917522?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 800 participants. The study started on 2023-12-07. Estimated completion is 2029-07.
What conditions does trial NCT05917522 study?
This clinical trial studies the following conditions: Kidney Transplant. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05917522?
The interventions under investigation include: Abatacept (BIOLOGICAL), Standard of Care at US Transplant Centers (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05917522?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05917522 being conducted?
This trial has 15 study locations across Alabama, California, Connecticut, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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