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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:6/22/2018
Start Date:August 2016
End Date:June 2017

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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

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).


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.
We found this trial at
14
sites
Freiburg, Baden Wuerttemberg 79106
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Freiburg,
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Alexandria, Louisiana 71301
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Alexandria, LA
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Birmingham, Alabama 35211
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from
Birmingham, AL
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Boise, Idaho 83712
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Boise, ID
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Concord, California 94520
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from
Concord, CA
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Danbury, Connecticut 06810
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from
Danbury, CT
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Durham, North Carolina 27705
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from
Durham, NC
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High Point, North Carolina 27262
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from
High Point, NC
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Huntsville, Alabama 35801
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from
Huntsville, AL
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16003 Florida Avenue
Jacksonville, Florida 32209
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Jacksonville, FL
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Littleton, Colorado 80120
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from
Littleton, CO
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Petoskey, Michigan 49770
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from
Petoskey, MI
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Rapid City, South Dakota 57701
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from
Rapid City, SD
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Wichita Falls, Texas 76301
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from
Wichita Falls, TX
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