Urine Testing to Detect Kidney Transplant Rejection

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: Kidney Transplantation; Kidney Failure, Chronic; Kidney Disease

Study type: Observational

Funder types: NIH

Identifiers

NCT00337220

DAIT CTOT-04

Details and patient eligibility

About

The purpose of this study is to determine if analysis of urine samples for specific markers can predict transplant rejection in people who have received kidney transplants.

Full description

Innovations in kidney transplantation have improved short-term outcomes for transplant patients. However, organ rejection remains as an important threat to the long-term survival of the transplanted organ. An increase in the serum creatinine level is often the first clinical indicator of kidney transplant rejection; however, this marker lacks sensitivity and specificity. Rejection is currently diagnosed using an invasive transplant biopsy procedure; in addition to being expensive, transplant biopsies can result in bleeding from the transplant and even graft loss. In early studies, it has been observed that significant increases in the levels of perforin, granzyme B, and CD3 messenger RNA (mRNA) in urinary cells signal the development of acute transplant rejection. The purpose of this study is to evaluate whether the noninvasive procedure of measuring perforin, granzyme B, and CD3 mRNA levels in urine samples can accurately diagnose and predict kidney transplant rejection, make transplant biopsy unnecessary, and provide an opportunity to initiate treatment for early rejection with the aim to minimize damage to the kidney.

This study will last 3 years post-transplant. There will be a total of 14 study visits. Blood and urine collection will occur at all visits. Additional visits may be necessary for those participants who develop abnormal kidney function.

Enrollment: 492 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled to undergo primary or redo deceased- or living-donor kidney transplantation
• Ability to provide informed consent

Exclusion criteria

• Requires combined organ transplantation
• Previously received a solid organ transplant (other than kidney transplant) or islet cell transplant
• HCV infected
• HIV infected