Validation of Gene Expression Markers of Renal Allograft Functional Decline

Kidney Transplant Recipients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782586
• Other study ID #: DAIT GEN-04
• Status: Completed
• Start date: March 2013
• Est. completion date: March 2018

Study information

• Verified date: October 2019
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Kidney Transplant Recipients

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Genomics of Transplantation Cooperative Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal Function Decline	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 year estimated GFR (eGFR) by MDRD equation of >40 ml/min.; 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%).; >20% decline in eGFR from 1 year post-transplant to latest follow-up point.; At least one eGFR (MDRD) interval < 60 ml/min.	Baseline to 1 year

External Links

•   Division of Allergy, Immunology, and Transplantation (DAIT)
•   National Institute of Allergy and Infectious Diseases (NIAID)