A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB

Conditions

• FSGS

Eligibility Criteria

Sex

ALL

Age

12 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• DMX-200 — DRUG
  DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor.
• Placebo — DRUG
  Patients will receive 120 mg capsules of Placebo twice daily

Study Details

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 FSGS who are being treated with an ARB. Given the rarity of the disease and the similarities between adults and pediatric patients with FSGS, Dimerix will also investigate the efficacy and safety of DMX 200 in adolescents aged 12 to 17 years. The double-blind period will be followed by an open-label extension (OLE) which aims to assess the long-term efficacy and safety of DMX 200 for up to 2 additional years.

Key Dates

Start date

May 30, 2022

Status verified

Feb 2026

Primary completion

Dec 31, 2029

Completion

Dec 31, 2029

Study Design

Enrollment

286 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: DMX-200 (repagermanium)
  Patients will receive 120 mg immediate release capsules of DMX-200 twice daily during the treatment period (104 weeks) OLE: Patients will receive 120 mg immediate release capsules of DMX-200 twice daily during the OLE period (108-212 weeks)
• Placebo Comparator: Placebo
  Patients will receive 120 mg immediate release capsules of Placebo twice daily

Primary Outcome Measure

Evaluate the efficacy of DMX-200 in terms of urine protein/creatinine ratio (PCR) in patients with FSGS who are receiving an ARB. [ Time Frame: Baseline to Week 35 ]

Central Contacts

• David Fuller
  +61 1300 813 321
  [email protected]
• Alisha Smith
  +61 1300 813 321
  [email protected]

Locations (54)

Find similar trials in Birmingham, AL

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