Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients
Recruiting now
Conditions studied: Acute Rejection (AR) of Transplanted Kidney, Chronic Allograft Nephropathy (CAN), Interstitial Fibrosis (IF), Tubular Atrophy (TA)
In brief
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.
Key facts
- Study ID
- NCT01531257
- Run by
- Northwestern University
- People needed
- 1000
- Starts
- 2010-04-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-05-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female recipients of all races, ≥18 years of age.
- Patients undergoing primary or subsequent deceased-donor or living donor kidney transplantation.
- Subject and/or guardian must be able to provide informed consent.
- Subject and/or guardian must be able to comply with the study protocol.
You may not qualify if…
- Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
- Recipients of previous non-renal solid organ and/or islet cell transplantation.
- Infection with HIV.
- Inability or unwillingness of a participant and/or guardian to provide informed consent
Where it is running
- Northwestern University — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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