- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00319527
Retrospective Study: Long-term Health of Living Kidney Donors
February 23, 2024 updated by: Amit Garg, Lawson Health Research Institute
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
311
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
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital
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Alberta
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Edmonton, Alberta, Canada, T6G 2G3
- University of Alberta
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- St. Paul's Hospital
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V8
- Dalhousie University
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Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Hospital
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London, Ontario, Canada, N5A 4G5
- London Health Sciences Centre
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Ottawa, Ontario, Canada, K1H 7W9
- The Ottawa Hospital
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Toronto, Ontario, Canada
- University Health Network
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Toronto, Ontario, Canada
- St Michaels Hospital
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Glasgow, United Kingdom
- Western Infirmary
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Living Kidney Donors
Description
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
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amit X Garg, MD, Lawson Health Research Institute
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
May 1, 2004
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
April 27, 2006
First Submitted That Met QC Criteria
April 27, 2006
First Posted (Estimated)
April 27, 2006
Study Record Updates
Last Update Posted (Estimated)
February 26, 2024
Last Update Submitted That Met QC Criteria
February 23, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-04-078
- LKD Retrospective Study
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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