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

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.

Study Overview

• Status: Completed
• Conditions: Delayed Graft Function

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis Transplant Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 82 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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 who will be receiving "for cause" biopsies in the setting of an elevated serum creatinine or proteinuria. Samples of blood, and formalin-fixed, paraffin-embedded biopsy tissue will be sent to Transplant Genomics INC. (TGI) for study purposes. In addition, clinical data will be collected on each subject.. Blood and tissue will be analyzed by TGI using Affymetrix microarrays, and reports will be sent to UC Davis retrospectively. Samples may be batch-shipped and results will not be reported in real time. These results will be compared to both the histological diagnosis, and to the clinical course.

Description

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

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Phase 1; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biopsy prove acute rejection	Incidence of acute rejection at the time of any kidney biopsy	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene Expression Profiling	Blood and tissue collection from each subject at the time of each for cause or protocol kidney biopsy	12 months

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Northwestern University
• Investigators: Principal Investigator: Angelo DeMattos, MD, University of California, Davis Health Systems

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 22, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Estimate): May 25, 2016
• Last Update Submitted That Met QC Criteria: May 23, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: proteinuria; Renal Biopsy; elevated serum creatinine
• Additional Relevant MeSH Terms: Pathologic Processes; Delayed Graft Function
• Other Study ID Numbers: 665869