Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients

Kidney Transplantation Clinical Trial

Official title: Noninvasive Monitoring to Predict Outcome in De Novo Kidney Transplant Recipients

Status Completed

Clinical Trial Summary

The purpose of this study is to test noninvasive methods to monitor the health and condition of new kidneys 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. If clinicians could better monitor the condition of the organ after transplantation, they may be able to improve the chance of graft survival. Noninvasive ways to monitor the condition of the transplanted organ need to be developed and tested. This observational study will investigate whether certain blood and urine tests are useful in monitoring the health of transplanted kidneys.

This trial will involve 14 post-transplant study visits over the course of 2 years. A physical exam, medication history, adverse events assessment, and blood and urine collection will occur at all visits. Kidney biopsies will occur at study entry prior to transplantation and at Month 6, in adult participants only. Protocol biopsies are optional in the pediatric substudy group. Additional visits may be required if organ rejection is suspected. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Transplantation

• NCT number: NCT00308802
• Study type: Observational
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: N/A
• Start date: March 2006
• Completion date: July 2011