Actively Recruiting
Assessment of Biomarker-Guided Calcineurin Inhibitor Substitution in Kidney Transplantation (RTB-015)
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-03-23
800
Participants Needed
15
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adult first-time kidney transplant recipients to evaluate the Human Leukocyte Antigen (HLA)-DR/DQ molecular mismatch (mMM) score as a biomarker for predicting post-transplant immune risk. The study includes an observational phase and a nested randomized controlled trial (RCT) to assess whether switching from Tacrolimus to abatacept improves kidney function and other health outcomes while maintaining rejection prevention. The study enrolls 800 adults in the observational phase to track HLA-DR/DQ mMM scores and monitor immune events over 24 months. At six months post-transplant, about 300 eligible participants without rejection or infection and meeting immune criteria will be randomized to either abatacept with a tapering of Tacrolimus or standard care with continued Tacrolimus. The abatacept group receives weekly injections of 125 mg for 18 months, with close monitoring. Participants will be followed closely with biopsies, kidney function tests, neurocognitive assessments, and patient-reported outcome measures for up to 24 months. Safety and efficacy will be monitored, including tracking any acute rejection events. Those experiencing rejection will have samples collected for analysis. The research aims to validate the biomarker and assess treatment effects on kidney and cognitive health, along with quality of life.
CONDITIONS
Brief Title
Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide informed consent
- Adults aged 18 to 70 years
- First-time recipient of an ABO-compatible kidney transplant
- Panel Reactive Antibody ≤60% as per local assessment
- Negative virtual cross-match or donor-specific antibody negative within 14 days post-transplant
- Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception
- Hepatitis C antibody positive with negative PCR or in remission are eligible
- Vaccinations up to date per transplant trial guidance
- On triple immunosuppression: Tacrolimus with specific target levels, Mycophenolate mofetil ≥500 mg twice daily or Mycophenolate sodium ≥360 mg twice daily, and prednisone at least 5 mg daily
- For Nested RCT: no biopsy-proven acute rejection or donor-specific antibody at 6 months, eGFR between 30-90 ml/min/1.73m², negative TB testing or completed latent TB treatment, able to receive subcutaneous therapy
You will not qualify if you...
- Unable or unwilling to provide informed consent or comply with study protocols
- Non-kidney organ transplant recipients
- Current use of immunomodulatory agents like Rituximab, anti-TNF monoclonal antibodies, Belatacept, abatacept, or Janus kinase inhibitors
- Kidney donor is an identical twin
- Epstein-Barr virus seronegative recipients
- Chronic obstructive pulmonary disease
- Untreated latent tuberculosis
- HIV infection
- Active hepatitis B infection
- Enrollment in another investigational trial
- Current diagnosed mental illness or substance abuse interfering with compliance
- Recent live attenuated vaccine within 4 weeks
- Use of investigational drugs within 8 weeks
- Use of Campath
- For Nested RCT: biopsy-proven acute rejection or treated rejection in first 6 months, positive donor-specific antibody 0-6 months post-transplant, acute interstitial inflammation on biopsy, recurrent or new glomerulonephropathy, active infection including BK, CMV or EBV viremia, inability to undergo biopsies, not on Tacrolimus/Mycophenolic Acid/Prednisone, thrombocytopenia (<50,000/mm³), pregnancy or unwillingness to use contraception, and recent use of immunomodulatory agents since enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 months post-kidney transplant
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit around the time of kidney transplant
Duration - Up to 24 months post-kidney transplant
Participants are followed to evaluate donor-recipient HLA-DR/DQ molecular mismatch as a risk-stratifying prognostic biomarker and monitor for alloimmune events.
Regular observational visits during the 24 months post-transplant
Duration - 18 months post-randomization (starting at 6 months post-transplant)
Eligible participants are randomized to receive either abatacept with tapering off calcineurin inhibitor or continue standard of care therapy, with monitoring for safety and kidney function.
Weekly abatacept injections and multiple follow-up visits over 18 months
Duration - Up to 24 months post-kidney transplant including 18 months post-randomization
Participants are monitored for renal function, neurocognitive function, and biopsy-proven acute rejection outcomes after treatment completion.
Follow-up visits continuing until study completion
Trial Site Locations
Total: 15 locations
1
University of Alabama School of Medicine: Transplantation
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Cedars Sinai Medical Center: Transplantation
Los Angeles, California, United States, 90048
Actively Recruiting
3
Ronald Reagan UCLA Medical Center: Transplantation
Los Angeles, California, United States, 90095
Actively Recruiting
4
Yale University, School of Medicine: Transplantation
New Haven, Connecticut, United States, 06519
Actively Recruiting
5
Johns Hopkins Hospital:Transplantation
Baltimore, Maryland, United States, 21287
Actively Recruiting
6
Massachusetts General Hospital: Transplantation
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
Mayo Clinic Rochester: Transplantation
Rochester, Minnesota, United States, 55905
Actively Recruiting
8
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
9
University of Nebraska Medical Center: Transplantation
Omaha, Nebraska, United States, 68198
Actively Recruiting
10
Duke University Medical Center: Transplantation
Durham, North Carolina, United States, 27710
Actively Recruiting
11
Cleveland Clinic Foundation: Transplantation
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
12
University of Pennsylvania Medical Center: Transplantation
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
13
University of Pittsburgh Medical Center: Transplantation
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
14
University of Virginia Health System: Transplantation
Charlottesville, Virginia, United States, 22908
Actively Recruiting
15
University of Wisconsin School of Medicine and Public Health: Transplantation
Madison, Wisconsin, United States, 53726
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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