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Validation of Gene Expression Markers of Renal Allograft Functional Decline

This study is ongoing, but not recruiting participants.
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: May 26, 2016
Last verified: May 2016
  Purpose
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
Kidney Transplant Recipients

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

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)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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. 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 ClinicalTrials.gov identifier: NCT01782586

Locations
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)
Investigators
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 
Study First Received: January 31, 2013
Last Updated: May 26, 2016
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on December 07, 2016