NCT00319527

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2004

Longer than P75 for all trials

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

3.8 years

First QC Date

April 27, 2006

Last Update Submit

February 23, 2024

Conditions

Kidney Diseases

Keywords

long term outcomeliving kidney donor

Study Arms (1)

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.).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Living Kidney Donors

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Dalhousie University

Halifax, Nova Scotia, B3H 1V8, Canada

Location

St. Joseph's Hospital

Hamilton, Ontario, L8N 4A6, Canada

Location

London Health Sciences Centre

London, Ontario, N5A 4G5, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

St Michaels Hospital

Toronto, Ontario, Canada

Location

University Health Network

Toronto, Ontario, Canada

Location

Western Infirmary

Glasgow, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine samples

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Amit X Garg, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nephrologist (London Health Sciences Centre)

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

May 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

CA(8)GB(1)AU(1)