Other Clinical Trial - Urine Testing to Detect Kidney Transplant Rejection

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00337220
Study type	Observational
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	N/A
Start date	June 2006
Completion date	December 2010

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04910867` - APOL1 Genetic Testing Program for Living Donors	N/A
Completed	`NCT02723591` - To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients	Phase 4
Completed	`NCT05945511` - Silent Gallbladder Stone in Kidney Transplantation Recipients: Should it be Treated?
Completed	`NCT02234349` - Bile Acids and Incretins in Pancreas Kidney Transplant Patients	N/A
Completed	`NCT04496401` - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus	Phase 4
Recruiting	`NCT05917795` - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates	N/A
Not yet recruiting	`NCT05934383` - Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension	N/A
Withdrawn	`NCT04936971` - Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response	Phase 4
Not yet recruiting	`NCT04540640` - Oxygenated Machine Preservation in Kidney Transplantation	N/A
Not yet recruiting	`NCT03090828` - Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease	N/A
Recruiting	`NCT02908139` - Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients	N/A
Completed	`NCT02560558` - Bela 8 Week Dosing	Phase 4
Terminated	`NCT02417870` - Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation	Phase 1/Phase 2
Recruiting	`NCT02154815` - Pre-emptive Kidney Transplantation Quality of Life	N/A
Completed	`NCT02235571` - iChoose Decision Kidney Aid for End-Stage Renal Disease Patients	N/A
Enrolling by invitation	`NCT01905514` - ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients	N/A
Completed	`NCT02147210` - Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1	N/A
Recruiting	`NCT01699360` - The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients	Phase 4
Terminated	`NCT01436305` - Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation	Phase 2
Completed	`NCT01655563` - Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation	Phase 2