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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Myocardial Infarction, Moderate Renal Impairment

In brief

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).

Key facts

Study ID

NCT02742103

Run by

CSL Behring

People needed

83

Starts

2016-08-01

Expected to finish

2017-06-01

Last updated by the study team

2020-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Study Site 16101 — Birmingham, Alabama, United States
• Study Site 16078 — Huntsville, Alabama, United States
• Study Site 16168 — Concord, California, United States
• Study Site 16130 — Littleton, Colorado, United States
• Study Site 16135 — Danbury, Connecticut, United States
• Study Site 16003 — Jacksonville, Florida, United States
• Study Site 16112 — Boise, Idaho, United States
• Study Site 16208 — Alexandria, Louisiana, United States
• Study Site 16061 — Petoskey, Michigan, United States
• Study Site 16056 — Durham, North Carolina, United States
• Study Site 16014 — High Point, North Carolina, United States
• Study Site 16018 — Rapid City, South Dakota, United States
• Study Site 16241 — Wichita Falls, Texas, United States
• Study Site 17001 — Freiburg im Breisgau, Baden-Wurttemberg, Germany
• Study Site 17014 — Frankfurt am Main, Hesse, Germany
• Study Site 17005 — Berlin, Germany
• Study Site 17009 — Berlin, Germany
• Study Site 17003 — Berlin, Germany
• Study Site 17006 — Hamburg, Germany
• Study Site 18001 — Budapest, Hungary
• Study Site 18005 — Budapest, Hungary
• Study Site 18007 — Nyíregyháza, Hungary
• Study Site 18003 — Pécs, Hungary
• Study Site 18009 — Szeged, Hungary
• Study Site 19005 — Haifa, Israel

Full record on ClinicalTrials.gov

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