Abatacept for Kidney Transplant Recipients

Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation

Recruiting Phase 2 Interventional Study
Kidney Transplant
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
800 (estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
Who this trial is looking for

This trial is looking for adults who are first-time kidney transplant recipients. Participants will be monitored to see how well their body accepts the new kidney and how well they can function over time.

Are You a Good Fit for This Trial?
Must be taking TacrolimusMycophenolateSteroid
Rules you out Chronic Obstructive Pulmonary DiseaseHIV infectionActive Hepatitis B infection

You may be able to join if

  • I can understand and give consent to participate
  • I am a first-time kidney transplant recipient
  • My blood test shows I have less than or equal to 60% Panel Reactive Antibody
  • I have a negative test for specific antibodies within 14 days post-transplant
  • I agree to use effective birth control if I can get pregnant
  • Vaccines are up to date as per guidelines
  • I am on triple immunosuppression treatment

You may not be able to join if

  • I am unable to provide consent or follow the study rules
  • I have had a kidney transplant from an identical twin
  • I have current lung disease or untreated latent tuberculosis
  • I am HIV positive or have an active hepatitis B infection
  • I am enrolled in another trial
  • I have a serious mental illness or substance abuse problem
  • I have had a live vaccine in the past 4 weeks
  • I have had recent treatment with investigational drugs

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Check Your Eligibility
About This Trial
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 wil…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Observational Study: 1. Subject must be able to understand and provide informed consent 2. Received (within 14 days) or candidate for an ABO-compatible kidney transplant, including A2 to B 3. Panel Reactive Antibody \<=60% as determined by local site 4. Virtual cross-match nega…
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