Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation
Public ClinicalTrials.gov record NCT05917522. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Assessment of Biomarker-Guided Calcineurin Inhibitor (CNI) Substitution In Kidney Transplantation (RTB-015)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05917522
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 800 participants
Conditions and interventions
Conditions
Interventions
- Abatacept Biological
- Standard of Care at US Transplant Centers Procedure
Biological · Procedure
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 6, 2023
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2029
- Last update posted
- Mar 22, 2026
2023 – 2029
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama School of Medicine: Transplantation | Birmingham | Alabama | 35233 | Recruiting |
| Cedars Sinai Medical Center: Transplantation | Los Angeles | California | 90048 | Recruiting |
| Ronald Reagan UCLA Medical Center: Transplantation | Los Angeles | California | 90095 | Recruiting |
| Yale University, School of Medicine: Transplantation | New Haven | Connecticut | 06519 | Recruiting |
| Johns Hopkins Hospital:Transplantation | Baltimore | Maryland | 21287 | Recruiting |
| Massachusetts General Hospital: Transplantation | Boston | Massachusetts | 02114 | Recruiting |
| Mayo Clinic Rochester: Transplantation | Rochester | Minnesota | 55905 | Recruiting |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | Recruiting |
| University of Nebraska Medical Center: Transplantation | Omaha | Nebraska | 68198 | Recruiting |
| Duke University Medical Center: Transplantation | Durham | North Carolina | 27710 | Recruiting |
| Cleveland Clinic Foundation: Transplantation | Cleveland | Ohio | 44195 | Not yet recruiting |
| University of Pennsylvania Medical Center: Transplantation | Philadelphia | Pennsylvania | 19104 | Recruiting |
| University of Pittsburgh Medical Center: Transplantation | Pittsburgh | Pennsylvania | 15213 | Recruiting |
| University of Virginia Health System: Transplantation | Charlottesville | Virginia | 22908 | Recruiting |
| University of Wisconsin School of Medicine and Public Health: Transplantation | Madison | Wisconsin | 53726 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05917522, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 22, 2026 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05917522 live on ClinicalTrials.gov.