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Alirocumab in Patients on a Stable Dialysis Regimen

StatusRecruiting
PhasePhase 3
Started
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.

Record History

  1. Primary completion date: Dec 31, 2019 to Aug 31, 2020
    • Study completion date: Jul 1, 2020 to Dec 31, 2020
    v5
  2. Primary completion date: Jun 5, 2019 to Dec 31, 2019
    • Study completion date: Sep 1, 2019 to Jul 1, 2020
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  4. Start date: Apr 1, 2018 to May 1, 2018v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03480568
Lead Sponsor Baylor Research Institute
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Hemodialysis, Peritoneal Dialysis, Hypercholesterolemia, Atherosclerotic Disease
Related terms Hypercholesterolemia
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov