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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308802
• Other study ID #: DAIT CTOT-01
• Status: Completed
• Phase: N/A
• First received: March 28, 2006
• Last updated: August 29, 2013
• Start date: March 2006
• Est. completion date: July 2011

Study information

• Verified date: August 2013
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Candidate for deceased donor or living donor kidney transplant

• Negative Crossmatch

• Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

• Clinically significant liver disease

• Other illnesses that, in the opinion of the investigator, may interfere with the study

• Recipient of multiple organ transplants

• Inability or unwillingness to comply with the study protocol

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Procedure:
• Kidney transplantation
Participants in this study will have had a kidney transplant

Locations

Country	Name	City	State
Canada	Children's Hospital of Winnipeg	Winnipeg	Manitoba
Canada	University of Manitoba	Winnipeg	Manitoba
United States	Emory Children's Center	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (4)

Hricik DE, Nickerson P, Formica RN, Poggio ED, Rush D, Newell KA, Goebel J, Gibson IW, Fairchild RL, Riggs M, Spain K, Ikle D, Bridges ND, Heeger PS; CTOT-01 consortium. Multicenter validation of urinary CXCL9 as a risk-stratifying biomarker for kidney tr — View Citation

Kaplan B, Srinivas TR, Meier-Kriesche HU. Factors associated with long-term renal allograft survival. Ther Drug Monit. 2002 Feb;24(1):36-9. Review. — View Citation

Meier-Kriesche HU, Schold JD, Kaplan B. Long-term renal allograft survival: have we made significant progress or is it time to rethink our analytic and therapeutic strategies? Am J Transplant. 2004 Aug;4(8):1289-95. — View Citation

Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378-83. — View Citation

External Links

•   Click here for the Clinical Trials in Organ Transplantation (CTOT) public Web site