FSGS Clinical Trial
A Pivotal Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of DMX-200 in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving an Angiotensin II Receptor Blocker (ARB)
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.
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 ;
|Enrolling by invitation||