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Abstract: INFO37

ACTION3 Pivotal Phase 3 Study Assessing the CCR2 Inhibitor DMX-200 (Repagermanium) in Adult Patients With Focal Segmental Glomerulosclerosis (FSGS)

Session Information

  • Informational Posters
    November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

  • No subcategory defined

Authors

  • Soman, Ashish, Dimerix Bioscience, Melbourne, Victoria, Australia
  • Barratt, Jonathan, Dimerix Bioscience, Melbourne, Victoria, Australia
  • Fornoni, Alessia, Dimerix Bioscience, Melbourne, Victoria, Australia
  • Inker, Lesley Ann, Dimerix Bioscience, Melbourne, Victoria, Australia
  • Shepherd, Robert, Dimerix Bioscience, Melbourne, Victoria, Australia
  • Smith, Alisha J., Dimerix Bioscience, Melbourne, Victoria, Australia
  • Wong, Muh Geot, Dimerix Bioscience, Melbourne, Victoria, Australia
  • L Heerspink, Hiddo Jan, Dimerix Bioscience, Melbourne, Victoria, Australia
Description

DMX-200 is a C-C chemokine receptor type 2 (CCR2) pathway inhibitor that when administered concurrently with an angiotensin II receptor blocker (ARB), is designed to inhibit recruitment of monocytes implicated in the inflammatory chemokine environment of chronic disease. Previous studies have shown the adjunct use of DMX-200 for 16 weeks reduced urine protein:creatinine rato (PCR) in patients with FSGS. ACTION3 is a pivotal randomized double-blind placebo-controlled Phase 3 clinical study to investigate the efficacy and safety of DMX-200 120 mg BID compared with placebo in 286 adult patients. The primary objective is to evaluate the efficacy of DMX-200 on reduction in PCR from a 24-hour urine sample after 35 weeks treatment and eGFR slope after 104 weeks treatment. Secondary objectives include evaluation of the safety and tolerability of DMX-200, and the effect of DMX-200 based on response criteria and composite endpoint of worsening in kidney function.
Eligible adult patients will be on a background ARB, have biopsy-proven primary FSGS, FSGS-UC or genetic FSGS and a uPCR of >1.5 g/g. Patients with secondary FSGS or that are on some immunomodulatory agents will be excluded from study participation.
Patients will be randomized in a 1:1 ratio to receive DMX-200 (BID) or matching placebo. The study will use a decentralized model, i.e., using a combination of on-site visits and optional remote visits.
Two interim analyses (IA) are planned: an Independent Data Monitoring Committee will perform a blinded IA for futility after the 72 patients complete 35 weeks of treatment. A second IA will be performed once approximately 144 patients complete 35 weeks of treatment. The final analysis will be performed once approximately 286 patients complete 104 weeks of treatment. The study is conducted in 11 countries at approximately 75 sites and has started enrolment. The study is expected to be completed in 2026.

Funding

  • The study is sponsored by Dimerix Bioscience Pty Ltd
Abstract: INFO37

ACTION3 Pivotal Phase 3 Study Assessing the CCR2 Inhibitor DMX-200 (Repagermanium) in Adult Patients With Focal Segmental Glomerulosclerosis (FSGS)

Session Information

  • Informational Posters
    November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Soman, Ashish, Dimerix Bioscience, Melbourne, Victoria, Australia
  • Barratt, Jonathan, Dimerix Bioscience, Melbourne, Victoria, Australia
  • Fornoni, Alessia, Dimerix Bioscience, Melbourne, Victoria, Australia
  • Inker, Lesley Ann, Dimerix Bioscience, Melbourne, Victoria, Australia
  • Shepherd, Robert, Dimerix Bioscience, Melbourne, Victoria, Australia
  • Smith, Alisha J., Dimerix Bioscience, Melbourne, Victoria, Australia
  • Wong, Muh Geot, Dimerix Bioscience, Melbourne, Victoria, Australia
  • L Heerspink, Hiddo Jan, Dimerix Bioscience, Melbourne, Victoria, Australia
Description

DMX-200 is a C-C chemokine receptor type 2 (CCR2) pathway inhibitor that when administered concurrently with an angiotensin II receptor blocker (ARB), is designed to inhibit recruitment of monocytes implicated in the inflammatory chemokine environment of chronic disease. Previous studies have shown the adjunct use of DMX-200 for 16 weeks reduced urine protein:creatinine rato (PCR) in patients with FSGS. ACTION3 is a pivotal randomized double-blind placebo-controlled Phase 3 clinical study to investigate the efficacy and safety of DMX-200 120 mg BID compared with placebo in 286 adult patients. The primary objective is to evaluate the efficacy of DMX-200 on reduction in PCR from a 24-hour urine sample after 35 weeks treatment and eGFR slope after 104 weeks treatment. Secondary objectives include evaluation of the safety and tolerability of DMX-200, and the effect of DMX-200 based on response criteria and composite endpoint of worsening in kidney function.
Eligible adult patients will be on a background ARB, have biopsy-proven primary FSGS, FSGS-UC or genetic FSGS and a uPCR of >1.5 g/g. Patients with secondary FSGS or that are on some immunomodulatory agents will be excluded from study participation.
Patients will be randomized in a 1:1 ratio to receive DMX-200 (BID) or matching placebo. The study will use a decentralized model, i.e., using a combination of on-site visits and optional remote visits.
Two interim analyses (IA) are planned: an Independent Data Monitoring Committee will perform a blinded IA for futility after the 72 patients complete 35 weeks of treatment. A second IA will be performed once approximately 144 patients complete 35 weeks of treatment. The final analysis will be performed once approximately 286 patients complete 104 weeks of treatment. The study is conducted in 11 countries at approximately 75 sites and has started enrolment. The study is expected to be completed in 2026.

Abstract: INFO37

ACTION3 Pivotal Phase 3 Study Assessing the CCR2 Inhibitor DMX-200 (Repagermanium) in Adult Patients With Focal Segmental Glomerulosclerosis (FSGS)

Session Information

  • Informational Posters
    November 05, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Soman, Ashish, Dimerix Bioscience, Melbourne, Victoria, Australia
  • Barratt, Jonathan, Dimerix Bioscience, Melbourne, Victoria, Australia
  • Fornoni, Alessia, Dimerix Bioscience, Melbourne, Victoria, Australia
  • Inker, Lesley Ann, Dimerix Bioscience, Melbourne, Victoria, Australia
  • Shepherd, Robert, Dimerix Bioscience, Melbourne, Victoria, Australia
  • Smith, Alisha J., Dimerix Bioscience, Melbourne, Victoria, Australia
  • Wong, Muh Geot, Dimerix Bioscience, Melbourne, Victoria, Australia
  • L Heerspink, Hiddo Jan, Dimerix Bioscience, Melbourne, Victoria, Australia
Description

DMX-200 is a C-C chemokine receptor type 2 (CCR2) pathway inhibitor that when administered concurrently with an angiotensin II receptor blocker (ARB), is designed to inhibit recruitment of monocytes implicated in the inflammatory chemokine environment of chronic disease. Previous studies have shown the adjunct use of DMX-200 for 16 weeks reduced urine protein:creatinine rato (PCR) in patients with FSGS. ACTION3 is a pivotal randomized double-blind placebo-controlled Phase 3 clinical study to investigate the efficacy and safety of DMX-200 120 mg BID compared with placebo in 286 adult patients. The primary objective is to evaluate the efficacy of DMX-200 on reduction in PCR from a 24-hour urine sample after 35 weeks treatment and eGFR slope after 104 weeks treatment. Secondary objectives include evaluation of the safety and tolerability of DMX-200, and the effect of DMX-200 based on response criteria and composite endpoint of worsening in kidney function.
Eligible adult patients will be on a background ARB, have biopsy-proven primary FSGS, FSGS-UC or genetic FSGS and a uPCR of >1.5 g/g. Patients with secondary FSGS or that are on some immunomodulatory agents will be excluded from study participation.
Patients will be randomized in a 1:1 ratio to receive DMX-200 (BID) or matching placebo. The study will use a decentralized model, i.e., using a combination of on-site visits and optional remote visits.
Two interim analyses (IA) are planned: an Independent Data Monitoring Committee will perform a blinded IA for futility after the 72 patients complete 35 weeks of treatment. A second IA will be performed once approximately 144 patients complete 35 weeks of treatment. The final analysis will be performed once approximately 286 patients complete 104 weeks of treatment. The study is conducted in 11 countries at approximately 75 sites and has started enrolment. The study is expected to be completed in 2026.