Living Kidney DonorsNCT00319579
Pilot Prospective Study: Long-term Health of Living Kidney Donors
An observational study of Living Kidney Donors, run by Amit Garg at 15 sites in 3 countries.
Trial summary
Kidney transplantation, a 'miracle' of modern medicine, is the preferred treatment option for End Stage Renal Disease compared to dialysis, patients who receive kidneys have a 70% reduction in risk of 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
- Living Kidney Donors
- How many people
- 330 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Jan 2005to Aug 2009
- 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
- A predicted Cockcroft-Gault creatinine clearance > 80 mL/min
- Average sBP < 140 and dBP < 90 based on 3 readings
- A spot urine protein to creatinine ratio < 15 mg/mmol
Who cannot join
- A medical condition (such as cardiovascular disease, pulmonary disease, active cancer) or psychological condition (such as major affective disorder, personality disorder, a history of chemical dependence) which the local transplant centre deems unfit for donation. Blood group and immunological incompatibility (such as positive cross-match, poor HLA matches) are not reasons for exclusion
- Evidence of a financial incentive for donation
- A contraindication to general anaesthesia or surgery
- A past medical history of hypertension
- Use of antihypertensive class medications for any reason.(ACE-Is, ARBs, diuretics, beta-blockers, calcium channel blockers)
- A past history of permanent proteinuria
Show all 12Show fewer
- The eligible non-donor is planning to donate their kidney within the next year
- Unable to give informed consent
- Unwilling to participate in the follow-up assessments at one, two, three, four and five years, or unwilling or unable to conduct home blood pressure or laboratory measurements
- The living donor or eligible non-donor is currently pregnant
- Despite being planned the donor nephrectomy does not take place
- Enrolled in another clinical study which interferes with the conduct or outcomes of this study
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
Canada8 sites
University of Alberta
Edmonton, Alberta, T6G 2GS
Dalhousie University
Halifax, Nova Scotia, B3H 1V8
St. Joseph Hospital
Hamilton, Ontario, L8N 4A6
London Health Sciences Centre
London, Ontario, N6C 6B5
The Ottawa Hospital
Ottawa, Ontario, K1H 7W9
St. Michael's Hospital
Toronto, Ontario, M5C 2T2
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
University of Manitoba
Winnipeg, Manitoba, R3A 1R9
United States5 sites
Cleveland Clinic
Cleveland, Ohio, 44195
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Wayne State University
Detroit, Michigan, 48201
Hume-Lee Transplant Center Renal/Pancreas Transplant Program
Richmond, Virginia, 23298-0274
Yale University and VAMC
West Haven, Connecticut, 06516
Australia2 sites
MonashMedical Centre
Clayton, Victoria, 3168
Sir Charles Gairdner Hospital
Nedlands, Western Australia
About this study
Official title: The Long Term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Prospective Pilot Study
Kidney transplantation, a 'miracle' of modern medicine, is the preferred treatment option for End Stage Renal Disease compared to dialysis, patients who receive kidneys have a 70% reduction in risk of death, a dramatically improved quality of life and cost the health care system considerably less. As a result there are over 3000 Canadians, and 57,000 Americans on the waiting list for a kidney. To meet the shortage in cadaveric kidneys, rates of living kidney donation have nearly doubled over the last 10 years, and will continue to rise with growing demand.
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 implications of living kidney donation are far less certain. This study will look at the long term implications of living kidney donation.
- Conditions
- Living Kidney Donors
- Keywords
- living kidney donors, prospective, medical, psychosocial
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 and meet certain criteria at the time of the donor's donation (i.e. no hypertension, no kidney disease, etc.). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension in living kidney donors
Measured: Annually for 5 years post donation
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 startJan 2005
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Living Kidney DonorsStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amit Garg
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-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
- NCT00319579
- Sponsor's protocol ID
- R-04-204
- Other IDs
- LKD Prospective Study
- Status last verified
- Feb 2024
- First submitted
- 27 Apr 2006
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Garcia-Ochoa C, Feldman LS, Nguan C, Monroy-Caudros M, Arnold JB, Barnieh L, Boudville N, Cuerden MS, Dipchand C, Gill JS, Karpinski M, Klarenbach S, Knoll G, Lok CE, Miller M, Prasad GVR, Sontrop JM, Storsley L, Garg AX. Impact of Perioperative Complications on Living Kidney Donor Health-Related Quality of Life and Mental Health: Results From a Prospective Cohort Study. Can J Kidney Health Dis. 2021 Aug 11;8:20543581211037429. doi: 10.1177/20543581211037429. eCollection 2021.
PubMed 34394947Garcia-Ochoa C, Feldman LS, Nguan C, Monroy-Cuadros M, Arnold J, Boudville N, Cuerden M, Dipchand C, Eng M, Gill J, Gourlay W, Karpinski M, Klarenbach S, Knoll G, Lentine KL, Lok CE, Luke P, Prasad GVR, Sener A, Sontrop JM, Storsley L, Treleaven D, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. Perioperative Complications During Living Donor Nephrectomy: Results From a Multicenter Cohort Study. Can J Kidney Health Dis. 2019 Jul 18;6:2054358119857718. doi: 10.1177/2054358119857718. eCollection 2019.
PubMed 31367455
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
- The Long Term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT00319579
- Acronym / sponsor ID
- R-04-204
- Conditions
- Living Kidney Donors
- Keywords
- living kidney donors, prospective, medical, psychosocial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Amit GargUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2005 (actual)
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (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, a 'miracle' of modern medicine, is the preferred treatment option for End Stage Renal Disease compared to dialysis, patients who receive kidneys have a 70% reduction in risk of death, a dramatically improved quality of life and cost the health care system considerably less. As a result there are over 3000 Canadians, and 57,000 Americans on the waiting list for a kidney. To meet the shortage in cadaveric kidneys, rates of living kidney donation have nearly doubled over the last 10 years, and will continue to rise with growing demand.
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 implications of living kidney donation are far less certain. This study will look at the long term implications of living kidney donation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Living Kidney Donors with controls who have not donated a kidney and meet 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 (4 listed)
- Age greater than 18 years old
- A predicted Cockcroft-Gault creatinine clearance > 80 mL/min
- Average sBP < 140 and dBP < 90 based on 3 readings
- A spot urine protein to creatinine ratio < 15 mg/mmol
Key exclusion criteria (12 listed)
- A medical condition (such as cardiovascular disease, pulmonary disease, active cancer) or psychological condition (such as major affective disorder, personality disorder, a history of chemical dependence) which the local transplant centre deems unfit for donation. Blood group and immunological incompatibility (such as positive cross-match, poor HLA matches) are not reasons for exclusion
- Evidence of a financial incentive for donation
- A contraindication to general anaesthesia or surgery
- A past medical history of hypertension
- Use of antihypertensive class medications for any reason.(ACE-Is, ARBs, diuretics, beta-blockers, calcium channel blockers)
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
Hypertension in living kidney donors
Time frame: Annually for 5 years post donation
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.
- Derived from this study: PubMed 34394947Garcia-Ochoa C, Feldman LS, Nguan C, Monroy-Caudros M, Arnold JB, Barnieh L, Boudville N, Cuerden MS, Dipchand C, Gill JS, Karpinski M, Klarenbach S, Knoll G, Lok CE, Miller M, Prasad GVR, Sontrop JM, Storsley L, Garg AX. Impact of Perioperative Complications on Living Kidney Donor Health-Related Quality of Life and Mental Health: Results From a Prospective Cohort Study. Can J Kidney Health Dis. 2021 Aug 11;8:20543581211037429. doi: 10.1177/20543581211037429. eCollection 2021.
- Derived from this study: PubMed 31367455Garcia-Ochoa C, Feldman LS, Nguan C, Monroy-Cuadros M, Arnold J, Boudville N, Cuerden M, Dipchand C, Eng M, Gill J, Gourlay W, Karpinski M, Klarenbach S, Knoll G, Lentine KL, Lok CE, Luke P, Prasad GVR, Sener A, Sontrop JM, Storsley L, Treleaven D, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. Perioperative Complications During Living Donor Nephrectomy: Results From a Multicenter Cohort Study. Can J Kidney Health Dis. 2019 Jul 18;6:2054358119857718. doi: 10.1177/2054358119857718. eCollection 2019.
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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
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Living Kidney Donors, run by Amit Garg at 15 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 4 inclusion and 12 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 15 sites in Canada, United States, Australia. 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.
What does the primary outcome measure?
Hypertension in living kidney donors (time frame: Annually for 5 years post donation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00319579, which also lists 2 linked publications.
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.