A phase 2 study of CSL112 in adults with moderate renal impairment and acute myocardial infarction

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003017-26-DE

Enrollment

Registered

2016-03-02

Start date

2016-07-21

Completion date

Unknown

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: Reconstituted High Density Lipoprotein Product Code: CSL112 Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: ongoing CAS Number: 51569670-111 Current Spon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Men or women aged at least 18 years of age, with body weight 50 kg or more • Evidence of moderate RI (estimated glomerular filtration rate [eGFR] = 30 and =65 years) yes F.1.3.1 Number of subjects for this age range 41

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the renal safety of CSL112 in subjects with moderate renal impairment (RI) and acute myocardial infarction (AMI) after up to 4 weekly administrations of CSL112;Secondary Objective: ·To further characterize the safety and tolerability of CSL112 in subjects with moderate RI and AMI. · To characterize the pharmacokinetics (PK) of CSL112 after multiple dose administration in subjects with moderate RI and AMI;Primary end point(s): 1. Incidence of treatment-emergent renal serious adverse event (SAE) 2. Incidence of treatment-emergent AKI ;Timepoint(s) of evaluation of this end point: 1. From the start of the first infusion to the end of the subject's participation in the study, up to approximately 9 weeks 2. From baseline (before infusion) through the active treatment period, approximately 1 month.	—

Measure

Time frame

Main Objective: To assess the renal safety of CSL112 in subjects with moderate renal impairment (RI) and acute myocardial infarction (AMI) after up to 4 weekly administrations of CSL112;Secondary Objective: ·To further characterize the safety and tolerability of CSL112 in subjects with moderate RI and AMI. · To characterize the pharmacokinetics (PK) of CSL112 after multiple dose administration in subjects with moderate RI and AMI;Primary end point(s): 1. Incidence of treatment-emergent renal serious adverse event (SAE) 2. Incidence of treatment-emergent AKI ;Timepoint(s) of evaluation of this end point: 1. From the start of the first infusion to the end of the subject's participation in the study, up to approximately 9 weeks 2. From baseline (before infusion) through the active treatment period, approximately 1 month.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Number of subjects with treatment-emergent AEs (TEAEs) 2. Percentage of subjects with TEAEs 3. The total number of TEAEs 4. Number of subjects with treatment-emergent adverse drug reaction (ADR) or suspected ADR 5. Percentage of subjects with treatment-emergent adverse drug reaction (ADR) or suspected ADR 6. Change in renal status - number of subjects 7. Change in renal status - percentage of subjects 8. Change in hepatic status - number of subjects 9. Change in hepatic status - percentage of subjects 10. Number of subjects with treatment-emergent bleeding events 11. Percentage of subjects with treatment-emergent bleeding events 12. Number of subjects with clinically significant changes in routine safety assessments 13. Percentage of subjects with clinically significant changes in routine safety assessments 14. Occurrence of binding antibodies 15. Baseline-corrected plasma apoA-I and phosphatidylcholine (PC) concentrations 16. Plasma apoA-I and PC concentration 17. Plasma apoA-I and PC accumulation ratio;Timepoint(s) of evaluation of this end point: 1 - 5; 10; 11: From the start of the first infusion to the end of the safety follow-up period, approximately 9 weeks for each subject 6 - 9: From baseline (before infusion) through the active treatment period, up to approximately 1 month 12 - 14: For the duration of the subject's participation in the study, up to approximately 9 weeks 15; 16: Before and at the end of the first infusion (day 1) and before and at the end of the fourth infusion (approximately 22 days), and within 48 hours after the start of the first infusion. 17: Before and at the end of the first infusion (day 1) and before and at the end of the fourth infusion (approximation 22 days)	—

Measure

Time frame

Secondary end point(s): 1. Number of subjects with treatment-emergent AEs (TEAEs) 2. Percentage of subjects with TEAEs 3. The total number of TEAEs 4. Number of subjects with treatment-emergent adverse drug reaction (ADR) or suspected ADR 5. Percentage of subjects with treatment-emergent adverse drug reaction (ADR) or suspected ADR 6. Change in renal status - number of subjects 7. Change in renal status - percentage of subjects 8. Change in hepatic status - number of subjects 9. Change in hepatic status - percentage of subjects 10. Number of subjects with treatment-emergent bleeding events 11. Percentage of subjects with treatment-emergent bleeding events 12. Number of subjects with clinically significant changes in routine safety assessments 13. Percentage of subjects with clinically significant changes in routine safety assessments 14. Occurrence of binding antibodies 15. Baseline-corrected plasma apoA-I and phosphatidylcholine (PC) concentrations 16. Plasma apoA-I and PC concentration 17. Plasma apoA-I and PC accumulation ratio;Timepoint(s) of evaluation of this end point: 1 - 5; 10; 11: From the start of the first infusion to the end of the safety follow-up period, approximately 9 weeks for each subject 6 - 9: From baseline (before infusion) through the active treatment period, up to approximately 1 month 12 - 14: For the duration of the subject's participation in the study, up to approximately 9 weeks 15; 16: Before and at the end of the first infusion (day 1) and before and at the end of the fourth infusion (approximately 22 days), and within 48 hours after the start of the first infusion. 17: Before and at the end of the first infusion (day 1) and before and at the end of the fourth infusion (approximation 22 days)

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Countries

European Union, Germany, Hungary, Israel, Netherlands, United States

Contacts

Public ContactTrial Registration Coordinator

CSL Behring

clinicaltrials@cslbehring.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026