Validation of Gene Expression Markers of Renal Allograft Functional Decline

October 2, 2019 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Multicenter Validation of Gene Expression Markers of Renal Allograft Functional Decline (GEN-04)

The purpose of this study is to determine if certain genes found in a kidney biopsy performed at one-year post transplant can predict which transplanted kidneys will have decreased kidney function within five years post-transplant.

Study Overview

Status

Completed

Conditions

Detailed Description

Gene expression profiling is used to study the activity of genes. Each gene has an "on/off" switch that controls how they are expressed in a cell, as well as a "volume control" that increases or decreases the level of expression of a particular gene as necessary. Researchers want to see if the presence and abundance of certain transcripts in a kidney biopsy at one year after transplant can predict which kidneys will have reduced function over time.

Study Type

Observational

Enrollment (Actual)

499

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Kidney transplant recipients

Description

Inclusion Criteria:

  • Adult (≥18 years) conventional renal transplant recipient.
  • Patients who have given informed consent and are willing to comply with the protocol.

Exclusion Criteria:

  • ABO incompatible kidney transplants.
  • Positive crossmatch kidney transplants (T cell crossmatch >100, B flow cytometric crossmatch >150).
  • Simultaneous kidney and extra-renal organ transplants including pancreas, liver, heart, lung, etc. Subjects who had previous extra renal transplants may be included in the study.
  • Patients taking chronic anticoagulation, which includes Coumadin, Plavix and any type of heparin. Aspirin is acceptable but must be stopped 5 days prior to the renal biopsy.
  • An inability to have the 1-year renal biopsy performed within the acceptable protocol window (Months 11-14 [Days 301-420] post-transplant).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Function Decline
Time Frame: Baseline to 1 year

The primary endpoint for this study is defined as a progressive decline in renal function in participants with good function at 1 year. These "Progressors" are defined by all of the following criteria:

  1. 1 year estimated GFR (eGFR) by MDRD equation of >40 ml/min.
  2. Decline in eGFR beyond 1 year during the time frame of this study (minimum 2.6 years after transplant and up to 5 years after transplant) with a slope of <-6.1% (i.e. slope of decline of renal function is >6.1%).
  3. >20% decline in eGFR from 1 year post-transplant to latest follow-up point.
  4. At least one eGFR (MDRD) interval < 60 ml/min.
Baseline to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Genomics of Transplantation Cooperative Research Program

Investigators

  • Principal Investigator: Mark D. Stegall, MD, Mayo Clinic, Rochester, MN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

January 31, 2013

First Posted (Estimate)

February 4, 2013

Study Record Updates

Last Update Posted (Actual)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DAIT GEN-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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