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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
Long-term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Historical Matched Cohort Study
Secondary ID [1] 0 0
LKD Retrospective Study
Secondary ID [2] 0 0
R-04-078
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Diseases 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.).
Comparator / control treatment
Control group

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
311
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Other
Name
Lawson Health Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Kidney Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00319527
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amit X Garg, MD
Address 0 0
Lawson Health Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00319527