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The Study of Long-term Deterioration of Kidney Transplants.

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Hennepin County Medical Center, Minneapolis
University of Alabama at Birmingham
University of Alberta
University of Iowa
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00217126
First received: September 16, 2005
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

This study is being done to create a kidney transplant database with information from many transplant centers for the purpose of studying ways to help improve transplant outcomes and the care of transplant recipients. This is also being done to learn why kidney transplant recipients have worsening of their kidney function, and whether there are specific findings that could result in future treatments.


Condition Phase
Kidney Transplant
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Kidney Function (2 Arms-Prospective and Retrospective)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Enrollment: 870
Study Start Date: October 2005
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Data will be collected from the participant's medical records, local health care providers and participant's to clarify or add any information. Participants will have samples of blood, and urine obtained during their routine visits, that will be saved for testing in this study. In addition, participant's receiving a kidney biopsy performed as a part of their clinical care, will have a piece of the biopsy used for the study. This study will be followed for five years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Kidney Transplant Recipients

Criteria

In the prospective group, all participants who will be receiving a kidney transplant are eligible. In the retrospective group, kidney transplant recipients who are undergoing a kidney biopsy to determine the cause of change in their serum creatine level.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217126

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
Hennepin County Medical Center, Minneapolis
University of Alabama at Birmingham
University of Alberta
University of Iowa
Investigators
Principal Investigator: Fernando G. Cosio, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Dr. Fernando Cosio, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00217126     History of Changes
Other Study ID Numbers: 143-05
Study First Received: September 16, 2005
Last Updated: January 2, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013