NCT02742103

A Study of CSL112 in Adults With Moderate Renal Impairment and Acute Myocardial Infarction

A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects With Moderate Renal Impairment and Acute Myocardial Infarction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase 2, multicenter, double-blind, randomized, placebo controlled, parallel-group study to investigate the renal safety and tolerability of multiple dose intravenous (IV) administration of CSL112 compared with placebo in subjects with moderate renal impairment (RI) and acute myocardial infarction (AMI).

Conditions

• Acute Myocardial Infarction
• Moderate Renal Impairment

Interventions

Type	Name	Description
BIOLOGICAL	CSL_112	CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.
OTHER	Placebo	0.9% weight/volume sodium chloride solution (ie, normal saline)

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-04-18
• Last updated: 2020-06-11
• Results posted: 2020-06-11

Locations

31 sites across 5 countries: United States, Germany, Hungary, Israel, Netherlands