A Study of CSL112 in Adults With Moderate Renal Impairment and Acute Myocardial Infarction

NCT ID: NCT02742103

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-06-30

Brief 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).

Conditions

Acute Myocardial Infarction; Moderate Renal Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

CSL_112

CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).

Group Type: EXPERIMENTAL

CSL_112

Intervention Type: BIOLOGICAL

CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.

Placebo

Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

0.9% weight/volume sodium chloride solution (ie, normal saline)

Interventions

CSL_112

CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.

Intervention Type: BIOLOGICAL

Placebo

0.9% weight/volume sodium chloride solution (ie, normal saline)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Duffy, MD

Role: STUDY_DIRECTOR

CSL Behring

Locations

Study Site 16101

Birmingham, Alabama, United States

Study Site 16078

Huntsville, Alabama, United States

Study Site 16168

Concord, California, United States

Study Site 16130

Littleton, Colorado, United States

Study Site 16135

Danbury, Connecticut, United States

Study Site 16003

Jacksonville, Florida, United States

Study Site 16112

Boise, Idaho, United States

Study Site 16208

Alexandria, Louisiana, United States

Study Site 16061

Petoskey, Michigan, United States

Study Site 16056

Durham, North Carolina, United States

Study Site 16014

High Point, North Carolina, United States

Study Site 16018

Rapid City, South Dakota, United States

Study Site 16241

Wichita Falls, Texas, United States

Study Site 17001

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Study Site 17014

Frankfurt am Main, Hesse, Germany

Study Site 17005

Berlin, , Germany

Study Site 17009

Berlin, , Germany

Study Site 17003

Berlin, , Germany

Study Site 17006

Hamburg, , Germany

Study Site 18001

Budapest, , Hungary

Study Site 18005

Budapest, , Hungary

Study Site 18007

Nyíregyháza, , Hungary

Study Site 18003

Pécs, , Hungary

Study Site 18009

Szeged, , Hungary

Study Site 19005

Haifa, , Israel

Study Site 19002

Nahariya, , Israel

Study Site 19008

Safed, , Israel

Study Site 21001

Alkmaar, , Netherlands

Study Site 21006

Amsterdam, , Netherlands

Study Site 21017

Amsterfoort, , Netherlands

Study Site 21008

Nijmegen, , Netherlands

Countries

United States; Germany; Hungary; Israel; Netherlands

References

Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.

Reference Type: DERIVED

PMID: 33217027 (View on PubMed)

Gibson CM, Kerneis M, Yee MK, Daaboul Y, Korjian S, Mehr AP, Tricoci P, Alexander JH, Kastelein JJP, Mehran R, Bode C, Lewis BS, Mehta R, Duffy D, Feaster J, Halabi M, Angiolillo DJ, Duerschmied D, Ophuis TO, Merkely B. The CSL112-2001 trial: Safety and tolerability of multiple doses of CSL112 (apolipoprotein A-I [human]), an intravenous formulation of plasma-derived apolipoprotein A-I, among subjects with moderate renal impairment after acute myocardial infarction. Am Heart J. 2019 Feb;208:81-90. doi: 10.1016/j.ahj.2018.11.008. Epub 2018 Nov 22.

Reference Type: DERIVED

PMID: 30580130 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-003017-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSL112_2001

Identifier Type: -

Identifier Source: org_study_id