Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Long-Term Study of Living Kidney Donors

This study has been completed.
Sponsor:
Collaborator:
National Kidney Foundation
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00319527
First received: April 27, 2006
Last updated: July 6, 2009
Last verified: July 2009
  Purpose

Kidney transplantation, is the preferred treatment option of end stage renal disease. Compared to dialysis, patients who receive kidneys have a 70% reduction in death, a dramatically improved quality of life and cost the health care system considerably less. As a result, there are over 3000 Canadians on the waiting list for a kidney. In order to meet the shortage of cadaveric kidneys, the rates of living kidney donation have nearly doubled over the last 10 years. Yet despite its advantages for the recipient, living kidney donation remains a complex ethical, moral, and medical issue. The premise for accepting living donors is that the "minimal" risk of short and long-term medical harm realized by the donor is outweighed by the definite advantages to the recipient and potential psychosocial benefits of the altruistic gift to the donor. The only benefit for the living donor is psychological - donors experience increased self-esteem, feelings of well-being, and improved health related quality of life with their altruistic act of assuming medical risk to help another. The short-term consequences of living donation are well established. On the other hand the long-term consequences of living kidney donation are far less certain. The main medical concerns of living kidney donation include an increased risk of hypertension, proteinuria, and low glomerular filtration rate (GFR- a measure of the filtering capacity of the kidney). Estimates of these outcomes are variable, inconsistent, and uncertain in the literature. This study is designed to quantify the long-term medical and psychosocial implications of living kidney donation.


Condition
Kidney Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-Term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Historical Matched Cohort Study

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Biospecimen Retention:   Samples Without DNA

Serum and urine samples


Enrollment: 311
Study Start Date: May 2004
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation
Living Kidney Donors with controls who have not donated a kidney or had certain criteria at the time of the donor's donation (i.e. no hypertension, no kidney disease, etc.).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Living Kidney Donors

Criteria

Inclusion Criteria:

  • Age greater than 18 years old
  • Living kidney transplant occurred between 1970 and 2006
  • no history of hypertension, kidney disease or proteinuria prior to donation

Exclusion Criteria:

  • a medical condition (such as cardiovascular disease, pulmonary disease, or active cancer) which makes one ineligible to be a donor. Blood group and immunological incompatibility (such as positive cross-match, poor HLA matches) are not reasons for exclusion.
  • The eligible non-donor subsequently went on to donate a kidney
  • Either the donor or the eligible non-donor are unable to give informed consent
  • The living donor or eligible non-donor is currently pregnant
  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: NCT00319527

Locations
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 1V8
Canada, Ontario
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
London Health Sciences Centre
London, Ontario, Canada, N5A 4G5
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 7W9
St Michaels Hospital
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
United Kingdom
Western Infirmary
Glasgow, United Kingdom
Sponsors and Collaborators
Lawson Health Research Institute
National Kidney Foundation
Investigators
Principal Investigator: Amit X Garg, MD Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: Dr. Amit Garg, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00319527     History of Changes
Other Study ID Numbers: R-04-078, LKD Retrospective Study
Study First Received: April 27, 2006
Last Updated: July 6, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
long term outcome
living kidney donor

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 24, 2014