Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Illinois
Northwestern University
RECRUITING
Chicago
Contact Information
Primary
Martha Castellini, BA
martha.castellini@northwestern.edu
Time Frame
Start Date: 2010-04
Estimated Completion Date: 2026-12
Participants
Target number of participants: 1000
Treatments
Kidney Transplant Recipients
The intention of our biomarker panel is to be broadly applicable to all patients with a kidney transplant with the assumption that there are common underlying molecular mechanisms of AR and CAN/IFTA that can be detected hopefully at early stages of disease. We therefore want to validate and test our biomarker panel in a broad collection of patient types. We chose not to include patients with dual organ transplants so that we could isolate the molecular signal we are studying.
Sponsors
Collaborators: Transplant Genomics, Inc.
Leads: Northwestern University

This content was sourced from clinicaltrials.gov