Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients

NCT01531257 | Recruiting

• 1 other identifier: STU 25946
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Rejection (AR) of Transplanted Kidney; Chronic Allograft Nephropathy (CAN); Interstitial Fibrosis (IF); Tubular Atrophy (TA)

Outcome Measures

Primary Outcomes (1)

• Gene Expression Profiling

  Full blood tube set, urine sample for proteomics and flow cytometry of urinary sediment, and an extra core kidney biopsy tissue for gene expression profiling will be collected from subjects at the time of any biopsies obtained during the study course. Whole genome expression profiling will be done using Affymetrix GeneChips at The Scripps Research Institute.

  At time of any protocol or for-cause kidney biopsy, up to 10 years post transplant.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present for routine care kidney transplant biopsies to the Comprehensive Transplant Center and who satisfy all of the eligibility criteria are approached for this research study.

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

Sponsors & Collaborators

• Northwestern University: lead
• Transplant Genomics, Inc.: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urine Collection: Approximately one cup of urine (200 mL) will be taken for research tests on the day of a routine care biopsy, if possible. Blood Draws: About 2.5 tablespoons of blood (38.5 mL) will be taken for research tests before the biopsy. Kidney Biopsy: A kidney biopsy is a procedure to remove and examine a small piece of kidney tissue. For this study, one biopsy will be taken from the new kidney and used specifically for research. The biopsy will be done at the same time as the biopsies done for routine care. If there are any complications during the routine care biopsies, the tissue for this research study will not be taken.

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sook H Park, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha Castellini, BA

CONTACT

martha.castellini@northwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 10, 2012
• Study Start: April 1, 2010
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)