Validation of Gene Expression Markers of Renal Allograft Functional Decline

Completed

Conditions studied: Kidney Transplant Recipients

In brief

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.

Key facts

Study ID

NCT01782586

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

499

Starts

2013-03-01

Expected to finish

2018-03-01

Last updated by the study team

2019-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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