Validation of Gene Expression Markers of Renal Allograft Functional Decline

NCT01782586 | Completed DMC

• 1 other identifier: DAIT GEN-04
• Study Type: observational
• Target: 499
• Locations: 1 country
• Sites: 4

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.

Conditions

Kidney Transplant Recipients

Keywords

kidney transplant; gene expression markers; renal allograft function

Outcome Measures

Primary Outcomes (1)

• 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. 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.

  Baseline to 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients

You may qualify if:

• Adult (≥18 years) conventional renal transplant recipient.
• Patients who have given informed consent and are willing to comply with the protocol.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Genomics of Transplantation Cooperative Research Program: collaborator

Study Sites (4)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

1-year surveillance biopsy and blood on 494 conventional kidney transplant participants from the 4 participating sites.

Study Officials

• Mark D. Stegall, MD

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 4, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 4, 2019

Record last verified: 2019-10

Locations

US (4)