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

CSL Behring

Status and phase: Completed; Phase 2

Conditions: Moderate Renal Impairment; Acute Myocardial Infarction

Treatments: Other: Placebo; Biological: CSL_112

Study type: Interventional

Funder types: Industry

Identifiers

NCT02742103

CSL112_2001

2015-003017-26 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women, at least 18 years of age, with evidence of moderate renal impairment (an eGFR ≥ 30 and <60 mL/min/1.73 m2) and myocardial necrosis in a clinical setting consistent with a type I (spontaneous) acute myocardial infarction (AMI).

Exclusion criteria

• Symptoms, biomarker elevation or electrocardiogram (ECG) changes other than those of the index event that are consistent with a diagnosis of AMI but are likely not due to primary myocardial ischemia
• Ongoing hemodynamic instability
• Planned coronary artery bypass surgery
• Evidence of hepatobiliary disease
• History of acute kidney injury (AKI) after previous exposure to an intravenous contrast agent.
• History of nephrotic range proteinuria.
• Known history of allergy to soy beans or peanuts, immunoglobulin A (IgA) deficiency, antibodies to IgA , or hypersensitivity to CSL112 or any of its components.
• Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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83 participants in 2 patient groups, including a placebo group

CSL_112

Experimental group

Description:

CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).

Treatment:

Biological: CSL_112

Placebo

Placebo Comparator group

Description:

Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.

Treatment:

Other: Placebo