CompletedNot Applicable

Domperidone and the Risk of Serious Adverse Events

Canada15,000 participantsStarted 2008-01-01

Plain-language summary

This study will assess whether initiating domperidone at doses ≥30 mg/day compared to \<30 mg/day in patients with advanced chronic kidney disease (CKD) (estimated glomerular filtration rate \[eGFR\] \<45 mL/min/1.73 m² but not receiving dialysis) is associated with a higher 30-day risk of a composite outcome of all-cause hospitalization or all-cause emergency visits or all-cause mortality.

Who can participate

Age range

66 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.

Exclusion criteria

. Data cleaning exclusions (e.g., missing or invalid age or sex, OHIP ineligible on index date, death on or before the index date, non-Ontario residents). The investigators anticipate that very few records will be excluded due to data cleaning.
. The investigators will exclude patients with unusual daily doses of less than 10 mg/day or \>40 mg/day for domperidone. The recommended maximum daily dose for domperidone is 10 mg three times daily (30 mg/day). Some patients may require doses up to 4 times daily.
. To ensure that patients are new domperidone users, the investigators will exclude those with any evidence of domperidone use in the 180 days before the index date.
. Patients with more than one eligible domperidone prescription on the index date will be excluded, as this complicates the ability to ascertain the prescribed dose accurately.
. The investigators will exclude patients with a prescription for any other prokinetic drugs and non-oral study drugs in the previous 180 days (including index date) (Note: - Gastrointestinal drugs (Cisapride, Metoclopramide, Domperidone, Prucalopride, Linaclotide)).

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

Number of participants with a composite outcome of all-cause hospitalization or all-cause emergency visits, or all-cause mortality

Timeframe: Exposed cohort to domperidone (high dose (≥30 mg/d) versus low dose (<30 mg/d)) will enter the cohort between January 1, 2008, and September 30, 2024, and will be followed until study outcome (first event), death, or 30 days from the cohort entry date.

Trial details

NCT IDNCT07098078

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Chronic Kidney Disease (CKD) trials