Pilot Prospective Study: Long-term Health of Living Kidney Donors

Completed

• Conditions: Living Kidney Donors

• Registration Number: NCT00319579
• Lead Sponsor: Amit Garg

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2006-04-27
• Study First Submitted QC: 2006-04-27
• Study First Posted: 2006-04-27
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

1. Age greater than 18 years old
2. A predicted Cockcroft-Gault creatinine clearance > 80 mL/min
3. Average sBP < 140 and dBP < 90 based on 3 readings
4. A spot urine protein to creatinine ratio < 15 mg/mmol

Exclusion Criteria

1. 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
2. Evidence of a financial incentive for donation
3. A contraindication to general anaesthesia or surgery
4. A past medical history of hypertension
5. Use of antihypertensive class medications for any reason.(ACE-Is, ARBs, diuretics, beta-blockers, calcium channel blockers)
6. A past history of permanent proteinuria
7. The eligible non-donor is planning to donate their kidney within the next year
8. Unable to give informed consent
9. 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
10. The living donor or eligible non-donor is currently pregnant
11. Despite being planned the donor nephrectomy does not take place
12. Enrolled in another clinical study which interferes with the conduct or outcomes of this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hypertension in living kidney donors	Annually for 5 years post donation

Trial Locations

Locations (15)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Dalhousie University; 🇨🇦 Halifax, Nova Scotia, Canada

MonashMedical Centre; 🇦🇺 Clayton, Victoria, Australia

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Sir Charles Gairdner Hospital; 🇦🇺 Nedlands, Western Australia, Australia

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Yale University and VAMC; 🇺🇸 West Haven, Connecticut, United States

St. Joseph Hospital; 🇨🇦 Hamilton, Ontario, Canada

University of Colorado Health Sciences Center; 🇺🇸 Denver, Colorado, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Hume-Lee Transplant Center Renal/Pancreas Transplant Program; 🇺🇸 Richmond, Virginia, United States