NCT04397653

Evolocumab Plus Ezetimibe in High Risk Haemodialized Statin Intolerant Patients

Status unknown Phase 4 Last updated 26 May 2020

What this trial tests

Phase 4 trial testing Evolocumab in Hypercholesterolemia in 50 participants. Status unknown.

Timeline

4 May 2020

Primary endpoint
19 November 2020

14 December 2020

Quick facts

Lead sponsor	Policlinico Casilino ASL RMB
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	50
Start date	4 May 2020
Primary completion	19 November 2020
Estimated completion	14 December 2020
Sites	1 location across Italy

Drugs / interventions tested

• Evolocumab (EVOLOCUMAB) — full drug profile →
• Placebo
• Ezetimibe (EZETIMIBE) — full drug profile →

Conditions studied

• Hypercholesterolemia — all drugs for Hypercholesterolemia →
• Chronic Kidney Disease Requiring Chronic Dialysis — all drugs for Chronic Kidney Disease Requiring Chronic Dialysis →

Sponsor

Policlinico Casilino ASL RMB

Who can join

Adults 18 to 80, any sex, with Hypercholesterolemia or Chronic Kidney Disease Requiring Chronic Dialysis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.