Skip to main content
OpenTrials
Completed

NCT Number: NCT00319579

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Living Kidney Donors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MonashMedical Centre, Clayton, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hypertension in living kidney donors

    Time frame: Annually for 5 years post donation

Sponsors and collaborators

Lead sponsor

Amit Garg

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

The Long Term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Prospective Pilot Study

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Apr 27, 2006
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.