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Clinical trial Recruiting at 1 site Observational Ages 18 and up

Monitoring kidney transplant recipients for rejection and damage

Official title: Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients

Run by Northwestern University · NCT01531257 · Data updated 2026-11-12

This study is trying to find better ways to monitor kidney transplant patients for signs of rejection and damage by collecting blood, urine, and biopsy samples.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment1000 (estimated)
SponsorNorthwestern University
Academic / other
Locations1 site (Chicago, Illinois)
StatusRecruiting
StartedApril 2010
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedMay 5, 2026
Trial IDNCT01531257 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adult kidney transplant recipients who are undergoing routine biopsies for monitoring purposes.

Probably not a fit

Patients requiring combined organ transplants or those with previous non-renal solid organ transplants may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on kidney transplant recipients to monitor and assess conditions like acute rejection and chronic allograft nephropathy. A total of 1000 subjects will be enrolled at Northwestern University, where they will undergo kidney biopsies at specified intervals or as needed. Blood, urine, and biopsy samples will be collected for proteomic analysis and gene expression profiling to better understand the early signs of kidney damage and rejection. The goal is to improve monitoring techniques beyond traditional methods, which may not detect early changes effectively.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for kidney transplant recipients, potentially enhancing graft survival.

How similar studies have gone: Other studies have shown promise in using proteomic and genomic approaches for monitoring transplant rejection, indicating potential success for this methodology.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male and female recipients of all races, ≥18 years of age.
2. Patients undergoing primary or subsequent deceased-donor or living donor kidney transplantation.
3. Subject and/or guardian must be able to provide informed consent.
4. Subject and/or guardian must be able to comply with the study protocol.

Exclusion Criteria:

1. Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
2. Recipients of previous non-renal solid organ and/or islet cell transplantation.
3. Infection with HIV.
4. Inability or unwillingness of a participant and/or guardian to provide informed consent

Where it's running

  • Northwestern University
    Chicago, Illinois, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.