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Monoclonal Antibodies

Alirocumab in Patients on a Stable Dialysis Regimen

Phase 3
Waitlist Available
Led By Cara East, MD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4, 8, 10, 12 weeks
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Pivotal Trial

Summary

This trial will test how well alirocumab works in patients with kidney disease who are on dialysis, and if it is safe for this population. Blood tests will be done to measure cholesterol and other markers. Safety events will be monitored throughout the study.

Eligible Conditions
  • Atherosclerosis
  • Coronary Artery Disease
  • High Cholesterol
  • Hemodialysis
  • Peritoneal Dialysis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4, 8, 10, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4, 8, 10, 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in LDL cholesterol levels
Secondary study objectives
Change in HDL-cholesterol levels
Change in apoprotein B levels
Other study objectives
Change in PCSK9 levels
Change in alirocumab drug levels

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: alirocumabExperimental Treatment1 Intervention
Alirocumab 150 mg q 2 weeks for 12 weeks

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
206 Previous Clinical Trials
203,405 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,804 Total Patients Enrolled
5 Trials studying Atherosclerosis
26,683 Patients Enrolled for Atherosclerosis
Cara East, MDPrincipal InvestigatorBaylor Research Institute
~3 spots leftby Jan 2026
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