Kidney DiseasesNCT00319527
Retrospective Study: Long-term Health of Living Kidney Donors
An observational study of Kidney Diseases, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Diseases
- How many people
- 311 participants
- Where
- 10 sitesin 3 countries
- Study dates
- May 2004to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Living Kidney Donors
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Canada8 sites
University of Alberta
Edmonton, Alberta, T6G 2G3
Dalhousie University
Halifax, Nova Scotia, B3H 1V8
St. Joseph's Hospital
Hamilton, Ontario, L8N 4A6
London Health Sciences Centre
London, Ontario, N5A 4G5
The Ottawa Hospital
Ottawa, Ontario, K1H 7W9
St Michaels Hospital
Toronto, Ontario
University Health Network
Toronto, Ontario
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Australia1 site
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
About this study
Official title: Long-term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Historical Matched Cohort Study
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
- Keywords
- long term outcome, living kidney donor
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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.). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startMay 2004
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- National Kidney Foundation, United States
- Responsible party
- Principal investigator, Amit Garg, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Amit X Garg, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319527
- Sponsor's protocol ID
- R-04-078
- Other IDs
- LKD Retrospective Study
- Status last verified
- Feb 2024
- First submitted
- 27 Apr 2006
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Historical Matched Cohort Study
- ClinicalTrials.gov ID
- NCT00319527
- Acronym / sponsor ID
- R-04-078
- Conditions
- Kidney Diseases
- Keywords
- long term outcome, living kidney donor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- National Kidney Foundation, United States
- Study start
- May 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 27 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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.). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Living Kidney Donors
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit X Garg, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Diseases, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada, Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.