Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients

August 29, 2013 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Noninvasive Monitoring to Predict Outcome in De Novo Kidney Transplant Recipients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • University of Manitoba
      • Winnipeg, Manitoba, Canada, R3A 151
        • Children's Hospital of Winnipeg
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30322
        • Emory Children's Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44195
        • University Hospitals of Cleveland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People who are candidates for kidney transplant

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

March 28, 2006

First Submitted That Met QC Criteria

March 28, 2006

First Posted (Estimate)

March 30, 2006

Study Record Updates

Last Update Posted (Estimate)

September 2, 2013

Last Update Submitted That Met QC Criteria

August 29, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DAIT CTOT-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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