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Clinical Trials in Canada / NCT07382960
Active, not recruiting Observational

Pramipexole and the Risk of Serious Adverse Events

NCT07382960 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2008-01-01
Last updated
2026-09-14

Condition(s) studied

Older Adults (65 Years and Older)Chronic Kidney Disease (CKD)

Investigational drug(s) / intervention(s)

Pramipexole →

Pramipexole: The primary exposure of interest will be oral pramipexole at a 0.125 mg/day. For the primary comparison, this dose has been selected to reduce the potential influence of indication bias.

Study 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.

Eligibility

Sex
ALL
Min age
66 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: The cohort will include older adults aged 66 years or older with advanced CKD (an eGFR \<45 mL/min per 1.73 m2 but not receiving dialysis or having a history of kidney transplantation) who have filled a new oral prescription for pramipexole at an outpatient pharmacy under the Ontario Drug Benefit (ODB) program from January 1, 2008, to December 01, 2024. The age criterion is set to guarantee that individuals in this population have had at least one year of prior prescription drug coverage. The date when the prescription was filled will serve as the patient's entry or index date for the cohort, with each patient entering the cohort only once. Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. 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. 5. Individuals with end-stage renal disease, chronic dialysis, or a kidney transplant prior to the index date. 6. 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. 7. Patients with no outpatient serum creatinine measurement 0- 365 days before the index date will be excluded. 8. 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. 9. The investigators will exclude patients receiving pramipexole doses other than 0.125, 0.25, or 0.375 mg/day. 10. If more than one eligible prescription is available, restrict it to the first. The date of this prescription will be the index date.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
London Health Sciences Centre Research Institute London Ontario

More London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's trials in Canada

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07382960 on ClinicalTrials.gov ↗ ← All trials in Canada