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Study identifier: NCT01531257 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients

Condition: Acute Rejection (AR) of Transplanted Kidney · Chronic Allograft Nephropathy (CAN) · Interstitial Fibrosis (IF)  ·  Sponsor: Northwestern University

PhaseN/A
Planned participants1000
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Chronic Allograft Nephropathy (CAN)/Interstitial fibrosis and Tubular Atrophy (IFTA) is responsible for most kidney transplant failures. CAN/IFTA on a 3 month kidney biopsy strongly predicts graft survival long term. CAN/IFTA remains a vexing problem for clinicians because current monitoring tools, namely the serum creatinine concentration, are not sensitive to early changes in glomerular filtration rate (GFR) or to histologic damage. Despite advances in prevention of acute rejection (AR), it is still a significant and potentially devastating complication of solid organ transplantation. One strategy to reduce the risk of rejection is to perform kidney biopsies to detect subclinical acute rejection (SCAR) and treat to prevent progression to rejection. There is evidence that treating SCAR can prevent further immune mediated injury to the kidney, a precursor to CAN/IFTA. Kidney biopsies provide better information but are limited due to safety concerns, patient preference and cost issues. Better, early and less invasive markers of CAN/IFTA will allow early intervention as well as improved graft and better patient outcomes. This study seeks to validate specific proteogenomic biomarker panels for AR and CAN/IFTA in a prospective blood, urine and kidney tissue monitoring study of kidney transplant recipients who will be scheduled for standard of care biopsies.

This description comes directly from the study's public registry record.

Talk to the study team

Martha Castellini, BA  ·  martha.castellini@northwestern.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Northwestern UniversityChicago, Illinois, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT01531257