This trial is active, not recruiting.

Condition kidney transplant recipients
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Start date February 2013
End date February 2018
Trial size 480 participants
Trial identifier NCT01782586, DAIT GEN-04


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Renal Function Decline
time frame: Baseline to 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Multicenter Validation of Gene Expression Markers of Renal Allograft Functional Decline (GEN-04)
Principal investigator MARK STEGALL, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID).