NCT00319579

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
3 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

4.6 years

First QC Date

April 27, 2006

Last Update Submit

February 23, 2024

Conditions

Living Kidney Donors

Keywords

living kidney donorsprospectivemedicalpsychosocial

Outcome Measures

Primary Outcomes (1)

  • Hypertension in living kidney donors

    Annually for 5 years post donation

Study Arms (1)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Living Kidney Donors

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:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

Yale University and VAMC

West Haven, Connecticut, 06516, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Hume-Lee Transplant Center Renal/Pancreas Transplant Program

Richmond, Virginia, 23298-0274, United States

Location

MonashMedical Centre

Clayton, Victoria, 3168, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Location

University of Alberta

Edmonton, Alberta, T6G 2GS, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Dalhousie University

Halifax, Nova Scotia, B3H 1V8, Canada

Location

St. Joseph Hospital

Hamilton, Ontario, L8N 4A6, Canada

Location

London Health Sciences Centre

London, Ontario, N6C 6B5, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (2)

  • Garcia-Ochoa C, Feldman LS, Nguan C, Monroy-Caudros M, Arnold JB, Barnieh L, Boudville N, Cuerden MS, Dipchand C, Gill JS, Karpinski M, Klarenbach S, Knoll G, Lok CE, Miller M, Prasad GVR, Sontrop JM, Storsley L, Garg AX. Impact of Perioperative Complications on Living Kidney Donor Health-Related Quality of Life and Mental Health: Results From a Prospective Cohort Study. Can J Kidney Health Dis. 2021 Aug 11;8:20543581211037429. doi: 10.1177/20543581211037429. eCollection 2021.

    PMID: 34394947DERIVED

  • Garcia-Ochoa C, Feldman LS, Nguan C, Monroy-Cuadros M, Arnold J, Boudville N, Cuerden M, Dipchand C, Eng M, Gill J, Gourlay W, Karpinski M, Klarenbach S, Knoll G, Lentine KL, Lok CE, Luke P, Prasad GVR, Sener A, Sontrop JM, Storsley L, Treleaven D, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. Perioperative Complications During Living Donor Nephrectomy: Results From a Multicenter Cohort Study. Can J Kidney Health Dis. 2019 Jul 18;6:2054358119857718. doi: 10.1177/2054358119857718. eCollection 2019.

    PMID: 31367455DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine samples

Study Officials

  • Amit X Garg, MD

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, MA, FRCPC, FACP, PhD

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

January 1, 2005

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

US(5)AU(2)CA(8)