What is abatacept studying for kidney transplant recipients?

Abatacept is being studied to see if switching from Tacrolimus to abatacept improves kidney function and other health outcomes after a kidney transplant. Researchers want to determine if abatacept can maintain immune health while reducing risks. This study is sponsored by the National Institute of Allergy and Infectious Diseases.

Who may be eligible for this kidney transplant clinical trial?

Adults aged 18 to 70 who have had their first kidney transplant and are on standard immunosuppression including Tacrolimus, Mycophenolate mofetil or sodium, and prednisone may be eligible. They must not have recent rejection or active infection and must be able to consent. Please review eligibility criteria for more details.

Is there any cost to participate in this kidney transplant clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 2

Age: 18Years - 70Years

All Genders

ID05917522

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

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying adult first-time kidney transplant recipients to evaluate the Human Leukocyte Antigen HLA-DRDQ 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-DRDQ 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

Age: 18Years - 70Years

All Genders

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

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