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Validation of Gene Expression Markers of Renal Allograft Functional Decline

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ClinicalTrials.gov Identifier: NCT01782586
Recruitment Status : Active, not recruiting
First Posted : February 4, 2013
Last Update Posted : June 8, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Kidney Transplant Recipients

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 Design

Study Type : Observational
Actual Enrollment : 480 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Validation of Gene Expression Markers of Renal Allograft Functional Decline (GEN-04)
Study Start Date : February 2013
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples With DNA
biopsy & blood on 480 conventional kidney transplant participants

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782586

United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: MARK STEGALL, MD Mayo Clinic, Rochester, MN
More Information

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01782586     History of Changes
Other Study ID Numbers: DAIT GEN-04
First Posted: February 4, 2013    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
kidney transplant
gene expression markers
renal allograft function