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
Boise, Idaho 83712
2248
mi
from 02139
Boise, ID
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Alexandria, Louisiana 71301
1399
mi
from 02139
Alexandria, LA
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Birmingham, Alabama 35211
1048
mi
from 02139
Birmingham, AL
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Concord, California 94520
2665
mi
from 02139
Concord, CA
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Danbury, Connecticut 06810
138
mi
from 02139
Danbury, CT
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Durham, North Carolina 27705
606
mi
from 02139
Durham, NC
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Freiburg, Baden Wuerttemberg 79106
3692
mi
from 02139
Freiburg,
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High Point, North Carolina 27262
775
mi
from 02139
High Point, NC
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Huntsville, Alabama 35801
984
mi
from 02139
Huntsville, AL
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16003 Florida Avenue
Jacksonville, Florida 32209
1035
mi
from 02139
Jacksonville, FL
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Littleton, Colorado 80120
1766
mi
from 02139
Littleton, CO
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Petoskey, Michigan 49770
719
mi
from 02139
Petoskey, MI
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Rapid City, South Dakota 57701
1611
mi
from 02139
Rapid City, SD
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Wichita Falls, Texas 76301
1590
mi
from 02139
Wichita Falls, TX
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