Validation of Gene Expression Markers of Renal Allograft Functional Decline

Completed

• Conditions: Kidney Transplant Recipients

• Registration Number: NCT01782586
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-04
• Study Start: 2013-03
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 499

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Renal Function Decline	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.

Trial Locations

Locations (2)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States