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

Completed

• Conditions: Delayed Graft Function

• Registration Number: NCT02463253
• Lead Sponsor: University of California, Davis

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-04
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biopsy prove acute rejection	12 months	Incidence of acute rejection at the time of any kidney biopsy

Secondary Outcome Measures

Name	Time	Method
Gene Expression Profiling	12 months	Blood and tissue collection from each subject at the time of each for cause or protocol kidney biopsy

Trial Locations

Locations (1)

University of California, Davis Transplant Center; 🇺🇸 Sacramento, California, United States