Clinical trial NCT00319527: Retrospective Study: Long-term Health of Living Kidney Donors
Official title: Long-term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Historical Matched Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Diseases
Keywords: long term outcome
living kidney donor
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: National Kidney Foundation, United States
First posted: 2006-04-27
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Living Kidney Donors

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: St Michaels Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Glasgow
country: United Kingdom
facility: Western Infirmary
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Amit X Garg, MD
role: PRINCIPAL_INVESTIGATOR
References: