RECRUITING

Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients

Quick Facts

Study Start:2010-04
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01531257

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male and female recipients of all races, ≥18 years of age.
  2. 2. Patients undergoing primary or subsequent deceased-donor or living donor kidney transplantation.
  3. 3. Subject and/or guardian must be able to provide informed consent.
  4. 4. Subject and/or guardian must be able to comply with the study protocol.
  1. 1. Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
  2. 2. Recipients of previous non-renal solid organ and/or islet cell transplantation.
  3. 3. Infection with HIV.
  4. 4. Inability or unwillingness of a participant and/or guardian to provide informed consent

Contacts and Locations

Study Contact

Jairo Chavez, BA
CONTACT
jairo.chavez@northwestern.edu

Principal Investigator

Sook H Park, MD
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Jairo Chavez
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Sook H Park, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2010-04
Study Completion Date2025-12

Study Record Updates

Study Start Date2010-04
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

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