A Prospective Study of Living Kidney Donation
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Purpose
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.
| Condition |
|---|
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Living Kidney Donors |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Long Term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Prospective Pilot Study |
- Hypertension in living kidney donors [ Time Frame: Annually for 5 years post donation ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Serum and urine samples
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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.).
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Living Kidney Donors
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Yale University and VAMC | |
| West Haven, Connecticut, United States, 06516 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Virginia | |
| Hume-Lee Transplant Center Renal/Pancreas Transplant Program | |
| Richmond, Virginia, United States, 23298-0274 | |
| Australia, Victoria | |
| MonashMedical Centre | |
| Clayton, Victoria, Australia, 3168 | |
| Australia, Western Australia | |
| Sir Charles Gairdner Hospital | |
| Nedlands, Western Australia, Australia | |
| Canada, Alberta | |
| University of Alberta | |
| Edmonton, Alberta, Canada, T6G 2GS | |
| Canada, British Columbia | |
| St. Paul's Hospital | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Canada, Manitoba | |
| University of Manitoba | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Canada, Nova Scotia | |
| Dalhousie University | |
| Halifax, Nova Scotia, Canada, B3H 1V8 | |
| Canada, Ontario | |
| St. Joseph Hospital | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| London Health Sciences Centre | |
| London, Ontario, Canada, N6C 6B5 | |
| The Ottawa Hospital | |
| Ottawa, Ontario, Canada, K1H 7W9 | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5C 2T2 | |
| Principal Investigator: | Amit X Garg, MD | Lawson Health Research Institute |
More Information
No publications provided
| Responsible Party: | Amit Garg, MD, MA, FRCPC, FACP, PhD, Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT00319579 History of Changes |
| Other Study ID Numbers: | R-04-204, LKD Prospective Study |
| Study First Received: | April 27, 2006 |
| Last Updated: | April 18, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Lawson Health Research Institute:
|
living kidney donors prospective medical psychosocial |
ClinicalTrials.gov processed this record on May 19, 2013