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Clinical trialNCT05917522RecruitingPhase 2Interventional

Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment800Kidney Transplant
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Peter Nickerson, M.D.

    University of Manitoba Max Rady College of Medicine - Transplantation

    Study Chair
  • Peter S Heeger, M.D.

    Cedars Sinai Medical Center: Transplantation

    Study Chair

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama School of Medicine: Transplantation

    Birmingham, Alabama, United States

    Gaurav Agarwal, M.D.
    Recruiting
  • Cedars Sinai Medical Center: Transplantation

    Los Angeles, California, United States

    Jun Shoji, M.D.
    Recruiting
  • Ronald Reagan Ucla Medical Center: Transplantation

    Los Angeles, California, United States

    Suphamai Bunnapradist, M.D.
    Recruiting
  • Yale University, School of Medicine: Transplantation

    New Haven, Connecticut, United States

    Richard Formica, M.D.
    Recruiting
  • Johns Hopkins Hospital:transplantation

    Baltimore, Maryland, United States

    Daniel Brennan, M.D.
    Recruiting
  • Massachusetts General Hospital: Transplantation

    Boston, Massachusetts, United States

    Leonardo Riella, M.D.
    Recruiting
  • Mayo Clinic Rochester: Transplantation

    Rochester, Minnesota, United States

    Carrie Schinstock, M.D.
    Recruiting
  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, United States

    Tarek Alhamad, M.D.
    Recruiting
  • University of Nebraska Medical Center: Transplantation

    Omaha, Nebraska, United States

    Eric Langewisch, M.D.
    Recruiting
  • Duke University Medical Center: Transplantation

    Durham, North Carolina, United States

    Debra Sudan, M.D.
    Recruiting
  • Cleveland Clinic Foundation: Transplantation

    Cleveland, Ohio, United States

    Emilio Poggio, M.D.
    Not, yet, recruiting
  • University of Pennsylvania Medical Center: Transplantation

    Philadelphia, Pennsylvania, United States

    Roy Bloom, M.D.
    Recruiting
  • University of Pittsburgh Medical Center: Transplantation

    Pittsburgh, Pennsylvania, United States

    Chethan Puttarajappa, M.D.
    Recruiting
  • University of Virginia Health System: Transplantation

    Charlottesville, Virginia, United States

    Alden Doyle, M.D.
    Recruiting
  • University of Wisconsin School of Medicine and Public Health: Transplantation

    Madison, Wisconsin, United States

    David Foley, M.D.
    Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
7 Dec 2023
Primary completion
31 Jul 2027
Completion
31 Jul 2029
Last update posted
23 Mar 2026
Registered enrollment
800
Registry id
NCT05917522

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.