Pramipexole and the Risk of Serious Adverse Events (NCT07382960) | Clinical Trial Compass
CompletedNot Applicable
Pramipexole and the Risk of Serious Adverse Events
Canada1,100 participantsStarted 2008-01-01
Plain-language summary
This is a population-based cohort study assessing whether initiation of a higher dose of pramipexole (0.25 or 0.375 mg/day), compared with a lower dose (0.125 mg/day), in older adults with advanced chronic kidney disease (CKD) (an estimated glomerular filtration rate \[eGFR\] \<45 mL/min/1.73 m² but not receiving dialysis or having a history of kidney transplantation) 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., individuals with missing or invalid age or sex or administrative database number, 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.
. To ensure that patients are new pramipexole users, the investigators will exclude those with any evidence of pramipexole use in the 180 days before the index date.
. Patients with more than one study drug 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 of dopamine agonists and non-oral study drugs in the previous 180 days, including the index date.
. Individuals with end-stage renal disease, chronic dialysis, or a kidney transplant prior to the index date.
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
Number of participants with a composite outcome of all-cause hospitalization or all-cause emergency visits, or all-cause mortality
Timeframe: Exposed cohort to pramipexole (high dose (0.25 or 0.375 mg/d)) versus (low dose (0.125 mg/d)) will enter the cohort and will be followed until study outcome (first event), death, or 30 days from the cohort entry date.
Trial details
NCT IDNCT07382960
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
. Evidence with hospital discharge or emergency department visit in the two days prior to or on the index date to ensure a new outpatient prescription.
. Patients with no outpatient serum creatinine measurement 0- 365 days before the index date will be excluded.
. Patients with unstable baseline kidney function (If the most recent serum creatinine test before the index date was an inpatient test \[ER or hospitalization\], and there is not at least one 'outpatient' serum creatinine in the year before test date 1) (If the most recent prior serum creatinine test before the index date was an inpatient test \[ER or hospitalization\], and while there is at least 'outpatient' serum creatinine test in the year before, the most recent outpatient test before differs by an eGFR 10 mL/min/1.73 m2 or more from the value on ) will be excluded. In Ontario, it has been shown that outpatient serum creatinine measurements in the province, conducted on a single occasion, indicate stable values.