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The Living Kidney Donor Safety Study

NCT00936078 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1438

Last updated 2024-08-06

No results posted yet for this study

Summary

The main goal of this study is to understand the long-term effects of kidney donation on blood pressure, kidney function, and patient-reported health-related quality of life. Living kidney donors and non-donor controls will be studied before and after the living donor transplant. The donors and non-donors will be followed for a minimum of 5 years and a maximum of 15 years. Both groups will be made up of healthy normotensive adults. The purpose of this study is to see if there are any long-term differences between the two groups regarding:

1. risk of hypertension
2. rate of kidney decline
3. risk of albuminuria
4. changes in health-related quality of life

The study also looks to assess other outcomes, including:

1. understand and quantify the expenses incurred by donors
2. understand donor factors which influence recipient outcomes

The pilot version of this study (The Long Term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Prospective Pilot Study) began in 2004. Donors and controls in the pilot study were given the opportunity to continue on in the main study once it started in 2009.

Conditions

  • Living Kidney Donation

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Astellas Pharma Canada, Inc.

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • Amit Garg, PhD, MD · London Health Sciences Centre

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2021-11-30
Completion
2022-03-31

Countries

  • Australia
  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00936078 on ClinicalTrials.gov