Acute Myocardial Infarction

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

NCT02742103 | PHASE 2 | INTERVENTIONAL

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).

31 Sites

83 Participants

Recruiting

18 Years to 64 Years

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Find closest sites:

SUBMIT

Study Site

Birmingham,Alabama,United States,35211

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Huntsville,Alabama,United States,35801

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Concord,California,United States,94520

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Littleton,Colorado,United States,80120

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Danbury,Connecticut,United States,06810

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Jacksonville,Florida,United States,32209

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Boise,Idaho,United States,83712

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Alexandria,Louisiana,United States,71301

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Petoskey,Michigan,United States,49770

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Durham,North Carolina,United States,27705

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High Point,North Carolina,United States,27762

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Rapid City,South Dakota,United States,57701

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Wichita Falls,Texas,United States,76301

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Freiburg,Baden Wuerttemberg,Germany,79106

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Frankfurt,Hessen,Germany,65929

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Berlin,Germany,10249

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Berlin,Germany,10967

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Berlin,Germany,13353

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Hamburg,Germany,20246

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Budapest,Hungary,1122

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Budapest,Hungary,1134

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Nyiregyhaza,Hungary,4400

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Pecs,Hungary,7624

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Szeged,Hungary,6720

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Haifa,Israel,3109601

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Nahariya,Israel,22100

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Safed,Israel,13100

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Alkmaar,Netherlands,1815JD

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Amsterdam,Netherlands,1091AC

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Amsterfoort,Netherlands,3818TZ

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Nijmegen,Netherlands,6525EC

Study Eligibility Criteria

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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov