CompletedNot Applicable

Long-term Risk of Cardiovascular Disease in Living Kidney Donors

50,000 participantsStarted 1992-07-01

Plain-language summary

The investigative team will conduct a population-based, matched retrospective cohort study across Ontario, Alberta, and British Columbia using linked administrative healthcare databases to evaluate the long-term risk of major adverse cardiovascular events (MACE) among living kidney donors compared with matched healthy nondonors. Living kidney donors who donated between 1992 and 2024 will be included and matched 1:10 to a carefully selected population of nondonors based on key demographic and clinical characteristics. The primary outcome is a composite of cardiovascular death, hospital admission for myocardial infarction, or hospital admission for ischaemic stroke. Secondary outcomes will examine each component of the composite separately and all-cause mortality. The results will provide evidence to inform clinical guidelines, support informed decision-making for potential donors and recipients, and guide counselling by transplant clinicians.

Who can participate

Age range

18 Years – 105 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.

\*Donors\* Inclusion Criteria: Living kidney donors who underwent donor nephrectomy in Ontario, Alberta, and British Columbia, Canada, between July 1, 1992, and March 31, 2024 are eligible to enter the study. Exclusion Criteria: * Any person with data errors in their database records (such as missing or invalid age; it is expected to exclude very few persons for these reasons). Data errors also include evidence of prior dialysis or a prior solid organ transplant, as such individuals are not eligible to become donors. * Any person who was not a permanent resident of the province (i.e., patient lives outside of the province, and only came to the province to donate a kidney to the intended recipient). This will include anyone who is not eligible for the province's health insurance plan, anyone whose date of last contact in the databases is less than 1 year after the cohort entry date, and any person without a physician visit in the last 1-year. * Any person who is \<18 years of age on the date of nephrectomy (as only under exceptional circumstances should a person less than 18 be approved for living donation). \*Non-donors\* Inclusion criteria: Before nephrectomy, living donors undergo rigorous health screening. A similarly healthy segment of the general population will be selected using restriction and matching. A random cohort-entry date will be assigned (simulated nephrectomy date) to all persons who were citizens in the province, according to the distribution of cohort-en…

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.

1This study is specifically looking at long-term cardiovascular risks after living kidney donation — what does the current evidence say about how donating a kidney might affect my own heart health and risk of major cardiac events over time?
2Since this trial has already been completed, has my doctor seen or reviewed any of its findings yet, and if so, do those results change how they would counsel me about my decision to donate?
3The study is tracking something called Major Adverse Cardiovascular Events, or MACE — can my doctor explain what events fall under that category and whether my personal health history puts me at higher or lower risk for those outcomes after donation?
4Before I consider donating, what cardiovascular screening or baseline testing would my care team do to understand my individual risk, especially given that this study was specifically designed to measure that kind of long-term outcome?
5Are there findings from this or similar studies that would lead my doctor to recommend against donation for someone with my specific health profile, and what alternatives exist if I'm not considered a low-risk candidate?

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

Major adverse cardiovascular event (MACE)

Timeframe: Donors and matched nondonors will enter the cohort between July 1, 1992 and March 31, 2024, and will be followed until study outcome (first event), non-CV death, emigration from the province, or the end of the observation period (March 31, 2025).

Trial details

NCT IDNCT07431515

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-03-31

View on ClinicalTrials.gov More Living Donor Nephrectomy trials