Actively Recruiting
Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-03-23
800
Participants Needed
15
Research Sites
290 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Adult (18 to 70 years old) first-time kidney transplant recipient or candidate within 14 days
- Panel Reactive Antibody 60% or less
- Negative virtual cross-match or Donor Specific Antibody (DSA) negative within 14 days post-transplant
- Female participants of childbearing potential must have a negative pregnancy test upon study entry
- Agree to use highly effective contraception during the study
- Hepatitis C antibody positive subjects with negative PCR (cleared infection or in remission) are eligible
- Up-to-date vaccines as per transplant trial guidelines
- Receiving triple immunosuppression: Calcineurin Inhibitor (Tacrolimus), Mycophenolic Acid (minimum doses specified), and Prednisone (minimum 5 mg daily)
- For the nested RCT, must have a 6-month biopsy free of acute rejection and negative DSA test
- eGFR between 30-90 ml/min/1.73m2 at 6 months
- Negative or treated latent tuberculosis testing within 52 weeks prior to randomization
- Able to receive subcutaneous therapy
You will not qualify if you...
- Unable or unwilling to provide informed consent or comply with study protocol
- Non-kidney transplant recipients
- Current use of immunomodulatory agents like Rituximab, anti-TNF antibodies, Belatacept, abatacept, or Janus kinase inhibitors
- Kidney transplant from an identical twin donor
- Epstein-Barr virus seronegative recipients
- Chronic obstructive pulmonary disease
- Untreated latent tuberculosis
- HIV infection
- Active Hepatitis B infection
- Participation in other investigational trials
- Current or recent diagnosed mental illness or substance abuse impacting compliance
- Recent live attenuated vaccine within 4 weeks
- Use of investigational drugs within 8 weeks
- Use of Campath
- For the nested RCT, history of biopsy proven acute rejection or donor-specific antibody positivity within 6 months
- Acute Banff interstitial inflammation score greater than 0 on 6-month biopsy
- Presence of glomerulonephropathy within 6 months
- Active viral infections including BK virus, CMV, or EBV viremia
- Not on Tacrolimus, Mycophenolic Acid, and Prednisone
- Thrombocytopenia (platelets less than 50,000/mm3)
- Pregnant or unwilling to use effective birth control
- Inability to administer subcutaneous therapy
AI-Screening
AI-Powered Screening
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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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