Clinical Trial

Alirocumab in Patients on a Stable Dialysis Regimen

Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated February 12, 2020 (before its estimated August 31, 2020 completion). Its status may not reflect the trial's current state.
Summary
12-week study of the efficacy and safety of alirocumab in patients maintained stably on hemodialysis or peritoneal dialysis. Measures of cholesterol levels, drug levels, PCSK9 levels, routine chemistry and cell counts, and biomarkers will be obtained at baseline and at weeks 4, 8, 10 and 12 weeks. Safety events will be obtained throughout the study.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2018-03-27; most recent amendment 2026-04-30.
Status change: Recruiting → Completed 2026-04-30
Status change: Not Yet Recruiting → Recruiting 2018-10-15
Trial Details
NCT Number NCT03480568
Lead Sponsor Baylor Research Institute
Collaborators: Regeneron Pharmaceuticals
Conditions Hemodialysis, Peritoneal Dialysis, Hypercholesterolemia, Atherosclerotic Disease
Enrollment 20 participants
Start Date 2018-05-01
Primary Completion 2020-08-31 (estimated)
Study Completion 2020-12-31 (estimated)
Updated on ClinicalTrials.gov 2020-02-12