Validation of Gene Expression Markers of Renal Allograft Functional Decline

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID) Identifier:
First received: January 31, 2013
Last updated: April 29, 2015
Last verified: April 2015

Researchers would like to see if it is possible to predict which transplanted kidneys will do better long term based on the gene expression within a kidney biopsy one year after transplant. 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.

Kidney Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Validation of Gene Expression Markers of Renal Allograft Functional Decline (GEN-04)

Resource links provided by NLM:

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Renal Function Decline [ Time Frame: Baseline to 1 year ] [ Designated as safety issue: No ]

    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.

Biospecimen Retention:   Samples With DNA

biopsy & blood on 480 conventional kidney transplant participants

Estimated Enrollment: 480
Study Start Date: February 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Kidney transplant recipients


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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01782586

United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Michael Leonard    480-342-2908      
Principal Investigator: Kunam Reddy, MD         
Sub-Investigator: Raymond Heilman, MD         
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Dana Kontras    904-953-8557      
Principal Investigator: Thomas Gonwa, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Iman Bajjoka    313-916-3709      
Principal Investigator: Kim Dean, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Cindy Groettum    507-266-8725      
Principal Investigator: Mark Stegall, MD         
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: MARK STEGALL, MD Mayo Clinic, Rochester, MN
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT01782586     History of Changes
Other Study ID Numbers: DAIT GEN-04
Study First Received: January 31, 2013
Last Updated: April 29, 2015
Health Authority: United States: Federal Government processed this record on October 13, 2015