Overview

This trial is active, not recruiting.

Condition living kidney donors
Sponsor Amit Garg
Collaborator Canadian Institutes of Health Research (CIHR)
Start date January 2005
End date December 2016
Trial size 600 participants
Trial identifier NCT00319579, LKD Prospective Study, R-04-204

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.).

Primary Outcomes

Measure
Hypertension in living kidney donors
time frame: Annually for 5 years post donation

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Long Term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Prospective Pilot Study
Principal investigator Amit X Garg, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Lawson Health Research Institute.