Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00308802
First received: March 28, 2006
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Kidney Transplantation
Procedure: Kidney transplantation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Noninvasive Monitoring to Predict Outcome in De Novo Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention:   Samples With DNA

Blood samples may be retained


Enrollment: 280
Study Start Date: March 2006
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Kidney transplantation
    Participants in this study will have had a kidney transplant
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People who are candidates for kidney transplant

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308802

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Georgia
Emory Children's Center
Atlanta, Georgia, United States, 30322
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44195
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3A 1R9
Children's Hospital of Winnipeg
Winnipeg, Manitoba, Canada, R3A 151
Sponsors and Collaborators
Investigators
Study Director: Peter S. Heeger, MD Mount Sinai School of Medicine
Principal Investigator: Donald Hricik, MD University Hospital Case Medical Center
Principal Investigator: David Rush, MD University of Manitoba at Winnipeg
Principal Investigator: Kenneth Newell, MD Emory University
Principal Investigator: Richard Formica, MD Yale University
Principal Investigator: Emilio Poggio, MD The Cleveland Clinic
Principal Investigator: Barry Warshaw, MD Emory-Children's Center
Principal Investigator: Enver Akalin, MD Mount Sinai School of Medicine
Principal Investigator: Patricia Birk, M.D. Children's Hospital of Winnipeg
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00308802     History of Changes
Other Study ID Numbers: DAIT CTOT-01
Study First Received: March 28, 2006
Last Updated: August 29, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Kidney
Transplant
Rejection
Kidney Disease
Kidney Failure
End Stage Renal Disease

ClinicalTrials.gov processed this record on October 21, 2014