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

April 27, 2006
July 6, 2009
May 2004
March 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00319527 on ClinicalTrials.gov Archive Site
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Long-Term Study of Living Kidney Donors
Long-Term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Historical Matched Cohort Study

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.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Retention:   Samples Without DNA
Description:

Serum and urine samples

Non-Probability Sample

Living Kidney Donors

Kidney Diseases
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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.).
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
311
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   United Kingdom
 
NCT00319527
R-04-078, LKD Retrospective Study
No
Dr. Amit Garg, Lawson Health Research Institute
Lawson Health Research Institute
National Kidney Foundation
Principal Investigator: Amit X Garg, MD Lawson Health Research Institute
Lawson Health Research Institute
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP