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A Prospective Study of Living Kidney Donation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Amit Garg, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00319579
First received: April 27, 2006
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition
Living Kidney Donors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Long Term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Prospective Pilot Study

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Hypertension in living kidney donors [ Time Frame: Annually for 5 years post donation ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum and urine samples


Estimated Enrollment: 600
Study Start Date: January 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Living Kidney Donors

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319579

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

No publications provided

Responsible Party: Amit Garg, MD, MA, FRCPC, FACP, PhD, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00319579     History of Changes
Other Study ID Numbers: R-04-204, LKD Prospective Study
Study First Received: April 27, 2006
Last Updated: April 18, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
living kidney donors
prospective
medical
psychosocial

ClinicalTrials.gov processed this record on November 20, 2014