drugset / Trial / NCT02742103
A Study of CSL112 in Adults With Moderate Renal Impairment and Acute Myocardial Infarction
RandomizedParallel-groupDouble-blindPrevention
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).
Timeline
- Start
- 2016-08
- Primary completion
- 2017-06
- Completion
- 2017-06
Outcome
Mixed primary results
registry analysis (other test); CSL_112 vs Placebo; Rate difference (CSL112 - placebo) -0.124 (95% CI -0.296 to -0.005); Newcombe-Wilson NCT02742103 ↗
registry analysis (other test); CSL_112 vs Placebo; Rate difference (CSL112 - placebo) -0.103 (95% CI -0.277 to 0.025); Newcombe-Wilson NCT02742103 ↗
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CSL112 | Protein / enzyme biologic | 6 g | Intravenous |