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 |
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).
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
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