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

February 23, 2024 updated by: Amit Garg

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • MonashMedical Centre
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Sir Charles Gairdner Hospital
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2GS
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • University of Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V8
        • Dalhousie University
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph Hospital
      • London, Ontario, Canada, N6C 6B5
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H 7W9
        • The Ottawa Hospital
      • Toronto, Ontario, Canada, M5C 2T2
        • St. Michael's Hospital
  • United States
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Health Sciences Center
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • Yale University and VAMC
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Virginia
      • Richmond, Virginia, United States, 23298-0274
        • Hume-Lee Transplant Center Renal/Pancreas Transplant Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Living Kidney Donors

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hypertension in living kidney donors
Time Frame: Annually for 5 years post donation
Annually for 5 years post donation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amit Garg

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Amit X Garg, MD, Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

April 27, 2006

First Submitted That Met QC Criteria

April 27, 2006

First Posted (Estimated)

April 27, 2006

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R-04-204
  • LKD Prospective Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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