Validation of Gene Expression Markers of Renal Allograft Functional Decline

National Institute of Allergy and Infectious Diseases (NIAID) logo

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Completed

Conditions

Kidney Transplant Recipients

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT01782586
DAIT GEN-04

Details and patient eligibility

About

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.

Full 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.

Enrollment

499 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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