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Clinical Trial Summary

DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor that, when administered concurrently with an ARB, is designed to inhibit recruitment of monocytes implicated in the inflammatory chemokine environment of chronic disease. The purpose of this pivotal randomized double-blind study is to investigate the efficacy and safety of DMX-200 120 mg twice daily (BID) compared with placebo over a treatment period of 104 weeks in adult patients with biopsy-proven FSGS who are being treated with an ARB.

Clinical Trial Description

This is a pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with FSGS. The total study duration per patient is estimated to be maximum of 122 weeks, including a 4-week Screening period, a Titration period (if required, for not more than 4 weeks), a 6-week Stabilization period, a 104-week Treatment period, and up to a 4-week off-treatment Follow-up period. This is a hybrid virtual study which will utilize a decentralized model, ie, using a combination of on-site visits and optional remote visits ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05183646
Study type Interventional
Source Dimerix Bioscience Pty Ltd
Contact Alisha Smith
Phone 1300 813 321
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date February 2022
Completion date June 2026

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