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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00319527
Registration number
NCT00319527
Ethics application status
Date submitted
27/04/2006
Date registered
27/04/2006
Date last updated
26/02/2024
Titles & IDs
Public title
Retrospective Study: Long-term Health of Living Kidney Donors
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Scientific title
Long-term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Historical Matched Cohort Study
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Secondary ID [1]
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LKD Retrospective Study
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Secondary ID [2]
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R-04-078
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Kidney Diseases
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2008
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Sample size
Target
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Accrual to date
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Final
311
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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State/province [2]
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British Columbia
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Country [3]
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Canada
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State/province [3]
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Nova Scotia
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Country [4]
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Canada
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State/province [4]
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Ontario
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Country [5]
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United Kingdom
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State/province [5]
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Glasgow
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Funding & Sponsors
Primary sponsor type
Other
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Name
Lawson Health Research Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Kidney Foundation
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT00319527
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Amit X Garg, MD
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Address
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Lawson Health Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00319527
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