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

Completed

Conditions studied: Living Kidney Donors

In brief

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.

Key facts

Study ID

NCT00319579

Run by

Amit Garg

People needed

330

Starts

2005-01-01

Expected to finish

2009-08-01

Last updated by the study team

2024-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado Health Sciences Center — Denver, Colorado, United States
• Yale University and VAMC — West Haven, Connecticut, United States
• Wayne State University — Detroit, Michigan, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Hume-Lee Transplant Center Renal/Pancreas Transplant Program — Richmond, Virginia, United States
• MonashMedical Centre — Clayton, Victoria, Australia
• Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
• University of Alberta — Edmonton, Alberta, Canada
• St. Paul's Hospital — Vancouver, British Columbia, Canada
• University of Manitoba — Winnipeg, Manitoba, Canada
• Dalhousie University — Halifax, Nova Scotia, Canada
• St. Joseph Hospital — Hamilton, Ontario, Canada
• London Health Sciences Centre — London, Ontario, Canada
• The Ottawa Hospital — Ottawa, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.