Long-Term Risk of Gout in Living Kidney Donors

NCT07546643 | Completed

• 1 other identifier: 2026 0906 443 007a
• Study Type: observational
• Target: 50,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This population-based, matched, retrospective cohort study will evaluate the long-term risk of gout among living kidney donors compared with matched healthy nondonors, using linked administrative health care databases from Ontario, Alberta, and British Columbia. Living kidney donors who donated between 1992 and 2024 will be identified and matched 1:10 to a carefully selected population of healthy nondonors based on baseline characteristics. The primary outcome is the first health care encounter with a diagnosis of gout. Secondary outcomes include receipt of a dispensed prescription for the composite of allopurinol, colchicine, or febuxostat, and each medication separately. The findings will provide evidence to inform clinical guidelines, support informed decision-making among potential donors and recipients, and guide counselling by transplant clinicians.

Conditions

Living Kidney Donation; Living Kidney Donor; Gout; Gout and Hyperuricemia

Keywords

gout; living kidney donation; kidney donor

Outcome Measures

Primary Outcomes (1)

• Diagnosis of gout

  The first health care encounter with gout recorded as a diagnosis ≥2 physician claims on separate days within 3 years (the second claim date will define the event date), an emergency department visit for gout, or hospitalization for gout.

  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), death, emigration from the province, or the end of the observation period (March 31, 2025).

Secondary Outcomes (1)

• Gout medications

  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), death, emigration from the province, or the end of the observation period (March 31, 2025).

Study Arms (2)

Living kidney donor cohort

Living kidney donors who had a donor nephrectomy between July 1, 1992 and March 31, 2024, at transplant centres in the provinces of Ontario, Alberta, and British Columbia. Each nephrectomy date will serve as the cohort entry date.

Procedure: Living kidney donation

Healthy non-donor cohort

A similarly healthy segment of the general provincial population selected using restriction and matching to emulate the health criteria required to be met for living kidney donation. A cohort entry date (simulated nephrectomy date) will be randomly assigned to all residents in the province, according to the distribution of cohort entry dates in the donor cohort (between July 1, 1992 and March 31, 2024).

Interventions

Living kidney donation PROCEDURE

Receipt of a nephrectomy for living kidney donation

Living kidney donor cohort

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Living kidney donors matched to nondonors from the general population with similar indicators of baseline health.

You may not qualify if:

• 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., the 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 last contact date in the databases is less than 1 year after the cohort entry date, and anyone without a physician visit in the year following the nephrectomy hospital discharge.
• 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).
• Any person with a history of gout.
• \*Non-donors\*
• Any person with data errors in their database records (such as missing or invalid age).
• Any person who was not a permanent resident of the province. This will include anyone who is not eligible for the province's health insurance plan and anyone whose last contact date in the databases is less than 1 year after the cohort entry date.
• Any person who is \<18 years of age on the cohort entry date.
• Anyone who is pregnant at the time of the cohort entry date.
• Baseline illnesses and measures of health care access from historic records preceding the cohort entry date will be identified. The sample of eligible nondonors will be restricted to persons without a recorded medical condition that could preclude donation. Such recorded medical conditions will include a hospitalization for mental illness in the prior year; an intensive care unit admission in the prior year; a hospitalization for palliative care services in the prior year; multiple hospital admissions in the prior year; high comorbidity (as assessed by the Charlson comorbidity index and adjusted clinical group scores, where data are available); receipt of home oxygen therapy; residence at a long-term care facility; dementia; any record of prior nephrology consultation or kidney disease (including receipt of dialysis, a kidney biopsy, or a kidney procedure such as a partial or complete nephrectomy); previous solid organ transplant; disorders of the kidneys, ureters, or bladder; any record of cardiovascular disease (congestive heart failure, cardiovascular procedures, myocardial infarction, peripheral vascular disease, abdominal aortic aneurysm repair, ischemic stroke); hypertension in individuals \<50 years of age (persons with this condition are not accepted as donors in Canada); any record of obstructive sleep apnea; any cancer diagnosis; any liver disease or cirrhosis; diabetes; any serious infection (hepatitis, HIV, infective endocarditis); any record of autoimmune rheumatic conditions (such as rheumatoid arthritis or systemic lupus erythematosus); and any record of alcoholism.
• To ensure the nondonors have access to health care services from physicians, nondonors who had no evidence of a family physician visit in the 2 years prior to cohort entry will be excluded. Additionally, nondonors with more than 5 family physician visits in the 2 years prior to cohort entry will be excluded, as this could suggest an active health issue that needs attention before donation could occur.
• Any person with a history of gout.

Sponsors & Collaborators

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

Related Publications (1)

• Lam NN, McArthur E, Kim SJ, Prasad GV, Lentine KL, Reese PP, Kasiske BL, Lok CE, Feldman LS, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network; Donor Nephrectomy Outcomes Research DONOR Network. Gout after living kidney donation: a matched cohort study. Am J Kidney Dis. 2015 Jun;65(6):925-32. doi: 10.1053/j.ajkd.2015.01.017. Epub 2015 Mar 25.

  PMID: 25818677 BACKGROUND

MeSH Terms

Conditions

Gout; Hyperuricemia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start: July 1, 1992
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share