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Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00308802
Recruitment Status : Completed
First Posted : March 30, 2006
Last Update Posted : September 2, 2013
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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.

Condition or disease Intervention/treatment
Kidney Transplantation Procedure: Kidney transplantation

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.

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Study Type : Observational
Actual Enrollment : 280 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Noninvasive Monitoring to Predict Outcome in De Novo Kidney Transplant Recipients
Study Start Date : March 2006
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

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

Biospecimen Retention:   Samples With DNA
Blood samples may be retained

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People who are candidates for kidney transplant

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308802

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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
Children's Hospital of Winnipeg
Winnipeg, Manitoba, Canada, R3A 151
University of Manitoba
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Director: Peter S. Heeger, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Donald Hricik, MD University Hospitals Cleveland 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 Icahn School of Medicine at Mount Sinai
Principal Investigator: Patricia Birk, M.D. Children's Hospital of Winnipeg
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00308802    
Other Study ID Numbers: DAIT CTOT-01
First Posted: March 30, 2006    Key Record Dates
Last Update Posted: September 2, 2013
Last Verified: August 2013
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Kidney Disease
Kidney Failure
End Stage Renal Disease