A phase 2 study of CSL112 in adults with moderate renal impairment and acute myocardial infarctio

Phase 1

Conditions: Acute Myocardial Infarction
MedDRA version: 19.0Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2015-003017-26-NL

Lead Sponsor: CSL Behring LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 81

Inclusion Criteria

• Men or women aged at least 18 years of age, with body weight 50 kg or more
• Evidence of moderate RI (estimated glomerular filtration rate [eGFR] = 30 and < 60 mL/min/1.73 m2) as calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation)
• Evidence of myocardial necrosis in a clinical setting consistent with a type I (spontaneous) AMI
• Documented evidence of stable hepatic and renal function and no clinical suspicion of acute kidney injury (AKI) at least 12 hours after the first medical contact for the index AMI.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 41

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): 1. Incidence of treatment-emergent renal serious adverse event (SAE)<br>2. Incidence of treatment-emergent AKI<br>;Timepoint(s) of evaluation of this end point: 1. From the start of the first infusion to the end of the subject's participation in the study, up to approximately 9 weeks<br>2. From baseline (before infusion) through the active treatment period, approximately 1 month.;Main Objective: To assess the renal safety of CSL112 in subjects with moderate renal impairment (RI) and acute myocardial infarction (AMI) after up to 4 weekly administrations of CSL112;Secondary Objective: ·To further characterize the safety and tolerability of CSL112 in subjects with moderate RI and AMI. <br>· To characterize the pharmacokinetics (PK) of CSL112 after multiple dose administration in subjects with moderate RI and AMI

Secondary Outcome Measures