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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

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

C Michael Gibson, Mathieu Kerneis, Megan K Yee, Yazan Daaboul, Serge Korjian, Ali Poyan Mehr, Pierluigi Tricoci, John H Alexander, John J P Kastelein, Roxana Mehran, Christoph Bode, Basil S Lewis, Ravindra Mehta, etc.

Am Heart J. 2019 Feb;208:81-90.

PMID: 30580130

Abstract:

Background:
CSL112 (apolipoprotein A-I [human]) is a plasma-derived apolipoprotein A-I developed for early reduction of cardiovascular risk following an acute myocardial infarction (AMI). The safety of CSL112 among AMI subjects with moderate, stage 3 chronic kidney disease (CKD) is unknown.
Methods:
CSL112_2001, a multicenter, placebo-controlled, parallel-group, double-blind, randomized phase 2 trial, enrolled patients with moderate CKD within 7 days following AMI. Enrollment was stratified on the basis of estimated glomerular filtration rate and presence of diabetes requiring treatment. Patients were randomized in a 2:1 ratio to receive 4 weekly infusions of CSL112 6 g or placebo. The co-primary safety end points were renal serious adverse events (SAEs) and acute kidney injury, defined as an increase ≥26.5 μmol/L in baseline serum creatinine for more than 24 hours, during the treatment period.
Results:
A total of 83 patients were randomized (55 CSL112 vs 28 placebo). No increase in renal SAEs was observed in the CSL112 group compared with placebo (CSL112 = 1 [1.9%], placebo = 4 [14.3%]). Similarly, no increase in acute kidney injury events was observed (CSL112 = 2 [4.0%], placebo = 4 [14.3%]). Rates of other SAEs were similar between groups. CSL112 administration resulted in increases in ApoA-I and cholesterol efflux similar to those observed in patients with AMI and normal renal function or stage 2 CKD enrolled in the ApoA-I Event Reducing in Ischemic Syndromes I trial.
Conclusions:
These results demonstrate the acceptable safety of the 6-g dose of CSL112 among AMI subjects with moderate stage 3 CKD and support inclusion of these patients in a phase 3 cardiovascular outcomes trial powered to assess efficacy.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
IAR4247083	Apolipoprotein A−I human			Price

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