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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be able to speak and read English and/or French, and
* Be able to provide informed consent, and
AND
Subjects must either:
* Be approved by the LHSC team (or applicable medical team at the participating sites) as eligible to donate their kidney and donated a kidney,
OR
* Meet study eligibility for controls (non-donors) as follows:
Be between the ages of 18 and 70 years
Meet blood pressure criteria as follows:
* Blood pressure \<140 mmHg systolic and \<90 mmHg diastolic based on an average of at least 3 blood pressure measurements taken during the recruitment interview, or an average blood pressure \< 140 mmHg systolic and \< 90 mmHg diastolic based on a minimum of 12 readings taken at home.
* All participants need to successfully record at least 12 home blood pressure readings using the self-monitoring device to be eligible
Meet local lab criteria as follows:
* Documented pre-donation serum creatinine \<115 µmol/L in men or \<90 µmol/L in women, or Cockcroft-Gault estimated glomerular filtration rate \>80 mL/min
* Urine dipstick test for protein is negative or if trace or 0.3 g/L, a random urine albumin to creatinine ratio \<8 mg/mmol (70 mg/g)
* Urine dipstick test for hematuria is negative. Those with non-persistent hematuria are eligible to participate. Those with initial evidence of dipstick hematuria may have a second assessment. Test should not occur during menses. Test should be repeated if there is evidence of urinary tract infection on…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hypertension
Timeframe: Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)
Trial details
NCT IDNCT00936078
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's