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
Alexandria, Louisiana 71301
797
mi
from 43215
Alexandria, LA
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Birmingham, Alabama 35211
491
mi
from 43215
Birmingham, AL
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Boise, Idaho 83712
1711
mi
from 43215
Boise, ID
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Concord, California 94520
2083
mi
from 43215
Concord, CA
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Danbury, Connecticut 06810
510
mi
from 43215
Danbury, CT
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Durham, North Carolina 27705
354
mi
from 43215
Durham, NC
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Freiburg, Baden Wuerttemberg 79106
4282
mi
from 43215
Freiburg,
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High Point, North Carolina 27262
303
mi
from 43215
High Point, NC
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Huntsville, Alabama 35801
409
mi
from 43215
Huntsville, AL
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16003 Florida Avenue
Jacksonville, Florida 32209
677
mi
from 43215
Jacksonville, FL
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Littleton, Colorado 80120
1164
mi
from 43215
Littleton, CO
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Petoskey, Michigan 49770
386
mi
from 43215
Petoskey, MI
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Rapid City, South Dakota 57701
1072
mi
from 43215
Rapid City, SD
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Wichita Falls, Texas 76301
949
mi
from 43215
Wichita Falls, TX
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