Correlation of Molecular Biomarkers With Biopsy Findings and Outcomes in Renal Transplant Recipients

University of California (UC) Davis

Status: Completed

Conditions: Delayed Graft Function

Study type: Observational

Funder types: Other

Identifiers

NCT02463253

665869

Details and patient eligibility

About

This is a single-center, prospective, non-randomized, observational study to evaluate specific proteogenomic biomarker panels for acute rejection (AR) and chronic allograft nephropathy/interstitial fibrosis and tubular atrophy (CAN/IFTA) in blood, urine and kidney tissue (biopsy) in kidney transplant recipients. Proteogenomic profiles will be routinely monitored over one year after enrollment.

Full description

OBJECTIVE: The objective of this phase of the study is to allow the clinical site to gain familiarity with patient recruitment, sample and data collection, and interpretation of the proteogenomic biomarker report provided, through retrospective analysis. This phase of the study will provide a platform for the transplant physicians to gain confidence with the format, logistics, and potential use of the biomarker tests on blood and tissue.

Enrollment: 20 patients

Sex: All

Ages: 18 to 82 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Patients who meet all of the following criteria are eligible for enrollment as study participants:

1. Male and female recipients of all races, ≥18 years of age.
2. Patients undergoing primary or subsequent deceased-donor or living donor kidney transplantation.
3. Subject and/or guardian must be able to provide informed consent.
4. Subject and/or guardian must be able to comply with the study protocol.

Exclusion Criteria:

1. Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.

2. Recipients of previous non-renal solid organ and/or islet cell transplantation

3. Infection with HIV.

4. Inability or unwillingness of a participant and/or guardian to provide informed consent

Trial design

20 participants in 1 patient group

Phase 1

Description:

A. OBJECTIVE: The objective of this phase of the study is to allow the clinical site to gain familiarity with patient recruitment, sample and data collection, and interpretation of the proteogenomic biomarker report provided, through retrospective analysis. This phase of the study will provide a platform for the transplant physicians to gain confidence with the format, logistics, and potential use of the biomarker tests on blood and tissue. B. STUDY DESIGN: Enroll 20 subjects who are post-transplant and are undergoing kidney transplant biopsies at the UC Davis transplant center. Ten subjects will be enrolled who are receiving surveillance "protocol biopsies" and 10 subjects.