Phase 2
N=83
A Study of CSL112 in Adults With Moderate Renal Impairment and Acute Myocardial Infarction
Acute Myocardial Infarction · Moderate Renal Impairment
Bottom Line
View on ClinicalTrials.gov: NCT02742103 ↗Enrolled (actual)
83
Serious AEs
27.5%
Results posted
Jun 2020
Primary outcome: Primary: Percent of Participants With at Least One Occurrence of Treatment-emergent Renal Serious Adverse Events (SAEs) (SAF) — 1.9; 14.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CSL_112 (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CSL Behring
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With at Least One Occurrence of Treatment-emergent Renal Serious Adverse Events (SAEs) (SAF) |
1.9; 14.3 | — |
| PRIMARY Percent of Participants With Treatment-emergent Acute Kidney Injury (AKI ) |
4.0; 14.3 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
38; 20 | — |
| SECONDARY Percentage of Participants With TEAEs |
73.1; 71.4 | — |
| SECONDARY Total Number of TEAEs |
111; 61 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Drug Reaction (ADR) or Suspected ADR |
30; 4 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Drug Reaction (ADR) or Suspected ADR |
57.7; 14.3 | — |
| SECONDARY Number of Participants With Change in Renal Status |
9; 3; 35; 18; 4; 4 | — |
| SECONDARY Percentage of Participants With Change in Renal Status |
17.3; 10.7; 67.3; 64.3; 7.7; 14.3 | — |
| SECONDARY Number of Participants With Change in Hepatic Status |
4; 1; 1; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Change in Hepatic Status |
7.7; 3.7; 1.9; 0; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-emergent Bleeding Events |
7; 5 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Bleeding Events |
13.5; 17.9 | — |
| SECONDARY Percentage of Participants With Binding Antibodies Specific to Apolipoprotein A-I (Apo-A1) and CSL112 |
0; 0; 0; 0 | — |
| SECONDARY Baseline-corrected Plasma Concentration Maximum (Cmax) After Infusion 1 for apoA-I and PC |
124.6; -4.5; 198.4; -4.9 | — |
| SECONDARY Baseline-corrected Plasma Concentration Maximum (Cmax) After Infusion 4 for apoA-I and PC |
141.5; 1.4; 200.0; -13.2 | — |
| SECONDARY Plasma apoA-I and Phosphatidylcholine (PC) Accumulation Ratio After Infusion 4 |
1.2; 1.0 | — |
Summary
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).
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.
Data sourced from ClinicalTrials.gov (NCT02742103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.