Evolocumab Plus Ezetimibe in High Risk Haemodialized Statin Intolerant Patients

Hypercholesterolemia Clinical Trial

Official title: Phase IV Study for Efficacy and Safety of Evolocumab Added to Ezetimibe (Standard of Care) in High Cardiovascular Risk Haemodialized Statin Intolerant Patients With Hypercholesterolemia

Status Recruiting

Clinical Trial Summary

Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol, reducing in turn the risk of cardiovascular events. Whether evolcumab is effective in haemodialized patients is uncertain. The investigators will conduct a randomized, double-blind, placebo-controlled trial to assess the feasibility, safety, and LDL-C-lowering efficacy of evolocumab in high cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia. Patients will be randomly assigned to receive evolocumab (140 mg subcutaneous every 2 weeks + ezetimibe 10 mg per os daily) or matching placebo (subcutaneous every 2 weeks + ezetimibe 10 mg per os daily) for 24 weeks. The primary efficacy end point will be the reduction in LDL-C ≥ 20 mg/dL from baseline. The key secondary efficacy end points will be: the reduction of LDL-C from baseline at 4, 6 and 12 weeks; the reduction of HDL-C, non-HDL cholesterol and triglycerides from baseline at 24 weeks; the number of patients achieving LDL-C <70 mg/dL. Every adverse event (serious and non-serious) correlated to drug infusion will be recorded (safety end-point).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Hypercholesterolemia
• Kidney Diseases
• Renal Insufficiency, Chronic

• NCT number: NCT04397653
• Study type: Interventional
• Source: Policlinico Casilino ASL RMB
• Contact: Gennaro Cice, MD
• Phone: 0039330915294
• Email: gennarocice@hormail.com
• Status: Recruiting
• Phase: Phase 4
• Start date: May 4, 2020
• Completion date: December 14, 2020