Retrospective Study: Long-term Health of Living Kidney Donors

NCT ID: NCT00319527

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 311 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2008-03-31

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.

Conditions

Kidney Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.).

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Kidney Foundation, United States

OTHER

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Amit Garg

Nephrologist (London Health Sciences Centre)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amit X Garg, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

University of Alberta

Edmonton, Alberta, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

Dalhousie University

Halifax, Nova Scotia, Canada

St. Joseph's Hospital

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

St Michaels Hospital

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Western Infirmary

Glasgow, , United Kingdom

Countries

Australia; Canada; United Kingdom

Other Identifiers

LKD Retrospective Study

Identifier Type: -

Identifier Source: secondary_id

R-04-078

Identifier Type: -

Identifier Source: org_study_id