Study of Alirocumab Given Every Two Weeks for 12 Weeks in Adults on Stable Hemodialysis or Peritoneal Dialysis

What this Trial Is About

This research aims to evaluate the effects of alirocumab, given every two weeks for 12 weeks, on cholesterol levels in patients who are stably maintained on hemodialysis or peritoneal dialysis. The study focuses on patients with end-stage renal disease receiving dialysis and seeks to demonstrate the drugs impact on lowering LDL cholesterol and other biomarkers. The trial also monitors safety and drug levels in this specific patient population. Participants receive alirocumab 150 mg administered by subcutaneous injection every two weeks for a total of 12 weeks. The study includes two groups of patients ten on hemodialysis and ten on peritoneal dialysis, all having been stable on their dialysis regimen for at least three months. The open-label design means all enrolled patients receive the drug without placebo comparison. Throughout the study, cholesterol levels, including LDL, HDL, and apoprotein B, are measured at baseline and at weeks 4, 8, and 12. Additional biomarkers and routine lab tests are also collected to assess safety and drug effects. Safety is closely monitored by recording adverse events and clinical changes during the entire 12-week treatment period. This allows researchers to understand how alirocumab affects cholesterol and related markers in dialysis patients under stable treatment conditions.

Alirocumab in Patients on a Stable Dialysis Regimen