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The Study of Long-term Deterioration of Kidney Transplants.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00217126
First Posted: September 22, 2005
Last Update Posted: January 3, 2013
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.
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
  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:


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

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Dr. Fernando Cosio, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00217126     History of Changes
Other Study ID Numbers: 143-05
First Submitted: September 16, 2005
First Posted: September 22, 2005
Last Update Posted: January 3, 2013
Last Verified: January 2013