Validation of Gene Expression Markers of Renal Allograft Functional Decline

This study is currently recruiting participants.
Verified August 2013 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01782586
First received: January 31, 2013
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

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.


Condition
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)
  Eligibility

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782586

Locations
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
Investigators
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)
ClinicalTrials.gov Identifier: NCT01782586     History of Changes
Other Study ID Numbers: DAIT GEN-04
Study First Received: January 31, 2013
Last Updated: August 2, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on April 17, 2014