Alirocumab in Patients on a Stable Dialysis Regimen

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT03480568
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 1, 2018
Status verified
Jan 2020
Primary completion
Aug 31, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: alirocumab
    Alirocumab 150 mg q 2 weeks for 12 weeks

Primary Outcome Measure

Change in LDL cholesterol levels [ Time Frame: Baseline, 4 ,8, 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor Soltero CV ResearchDallasTexas75226
Cara East, MD
[email protected]
214-820-2273
Merielle Boatman
[email protected]
214-820-2273
Cara East, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Baylor Soltero CV Research· Dallas, TX

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