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

Delayed Graft Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02463253
• Other study ID #: 665869
• Status: Completed
• Phase: N/A
• First received: April 22, 2015
• Last updated: May 23, 2016
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 82 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delayed Graft Function

Locations

Country	Name	City	State
United States	University of California, Davis Transplant Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biopsy prove acute rejection	Incidence of acute rejection at the time of any kidney biopsy	12 months	No
Secondary	Gene Expression Profiling	Blood and tissue collection from each subject at the time of each for cause or protocol kidney biopsy	12 months	No