Nortriptyline and the Risk of Serious Adverse Events

This is a population-based retrospective, new-user, active comparator cohort study assessing whether initiating a new outpatient prescription of high-dose nortriptyline (\>10-150 mg/day), compared with low-dose (10 mg/day), is associated with an increased 30-day risk of serious adverse events among older adults with low kidney function (estimated glomerular filtration rate \[eGFR\] \<45 ml/min/1.73m2) who are not receiving dialysis and have no history of kidney transplantation. The primary outcome is a 30-day composite of all-cause emergency department visit, all-cause hospitalization, or all-cause mortality.

NCT Number	NCT07527481
Lead Sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions	Chronic Kidney Disease
Enrollment	5,000 participants
Start Date	2008-01-01
Primary Completion	2025-12-01 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-09