Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)

Summary

This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo. Part 2: Phase 3 aims to assess the efficacy of CSL300 vs placebo on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.

Timeline

Start

2022-10-21

Primary completion

2029-05-22

Completion

2029-05-22

Publications

• Chertow GM, Chang AM, Felker GM, Heise M, Velkoska E, Fellstrom B, Charytan DM, Clementi R, Gibson CM, Goodman SG, Jardine M, Levin A, Lokhnygina Y, Mears J, Mehran R, Stenvinkel P, Wang AY, Wheeler DC, Zoccali C, Ridker PM, Mahaffey KW, Tricoci P, Wolf M. IL-6 inhibition with clazakizumab in patients receiving maintenance dialysis: a randomized phase 2b trial. Nat Med. 2024 Aug;30(8):2328-2336. doi: 10.1038/s41591-024-03043-1. Epub 2024 May 25.

Drugs

Indications