RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2022-05-30

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05183646

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients must be 12 to 80 years old 2. A diagnosis of primary FSGS, genetic FSGS, or FSGS of undetermined cause. Confirmed by kidney biopsy or documentation of a genetic mutation in a podocyte protein associated with FSGS 3. Must be either receiving an ARB at the maximal tolerated dose or willing to transition 4. If taking corticosteroids, the dosage must be stable for ≥4 weeks prior to Screening and during Stablization 5. If taking aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, sodium-glucose co-transporter-2 (SGLT2) inhibitors, or endothelin receptor antagonists (ERAs, including dual antagonists), the dose and regimen must be stable for ≥12 weeks prior to Screening and during Stablization 6. Urine PCR \>1.5 g/g (\>169.5 mg/mmol) or 24-hour total protein \>1.5 g/day based on 24-hour urine collection during Screening. 7. Estimated GFR ≥25 mL/min/1.73 m2 at Screening 8. Seated blood pressure ≤160/100 mm Hg (mean of 3 values) (patients ≥18 years of age) or between the 5th and 95th percentile for age, sex, and height 29 (patients \<18 years of age) at Screening. 9. Body weight ≥35 kg (all patients) AND a BMI ≤40 kg/m2 (patients ≥18 years of age) or between the 5th and 98th percentile for age and sex (patients \<18 years of age) at Screening. 10. A female patient is eligible to participate if she is not pregnant or planning to become pregnant during the study, not breastfeeding, and at least one of the following conditions applies: 1. Is not of childbearing potential 2. If of childbearing potential and beginning at menarche, agrees to use a highly effective method of contraception consistently during the treatment period. 11. A male patient with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception 12. A patient or parent/legal guardian (as appropriate) who is capable of giving signed informed consent, and where required, the patient is capable of providing assent.	1. Has FSGS secondary to another condition. 2. History of type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (defined as glycated hemoglobin \[HbA1c\] \>8%) 3. History of lymphoma, leukemia, or any active malignancy within the past 2 years 4. Active clinically significant hepatobiliary disease. 5. Documented history of heart failure (New York Heart Association Class III/IV) or a major adverse cardiac event within 12 weeks prior to Screening. 6. Has a physical, medical, or psychological condition, that in the opinion of the Investigator, may interfere with the evaluation the study. 7. The patient has a history of alcohol or illicit drug use disorder within 1 year prior to Screening. 8. Had a prior organ transplant or stem cell transplant, with the exception of corneal transplant. 9. Positive screening assessment for viral hepatitis B surface antigen, or anti-hepatitis C virus antibody AND positive HCV RNA, or human immunodeficiency virus 1 and 2. 10. Serum potassium levels \>5.5 mmol/L at Screening. 11. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2 × upper limit of normal (ULN) at Screening 12. Treatment with immunosuppressant biological drugs, calcineurin inhibitors, cyclophosphamide, azathioprine, or mycophenolate mofetil within 12 weeks prior to Screening. 13. History of serious side effects or allergic response to an angiotensin II antagonist or has a known sensitivity to any components in the Investigational Product. 14. Unable to swallow oral medication. 15. Prior participation in any Dimerix-sponsored DMX-200 clinical study. 16. Participation in a clinical study with an Investigational Product within 28 days or 5 half-lives (whichever is longer) prior to Screening or plans to participate in another study during the course of this study. 17. Are study site personnel directly affiliated with this study and their immediate families.

Inclusion Criteria

Exclusion Criteria

1. Patients must be 12 to 80 years old
2. A diagnosis of primary FSGS, genetic FSGS, or FSGS of undetermined cause. Confirmed by kidney biopsy or documentation of a genetic mutation in a podocyte protein associated with FSGS
3. Must be either receiving an ARB at the maximal tolerated dose or willing to transition
4. If taking corticosteroids, the dosage must be stable for ≥4 weeks prior to Screening and during Stablization
5. If taking aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, sodium-glucose co-transporter-2 (SGLT2) inhibitors, or endothelin receptor antagonists (ERAs, including dual antagonists), the dose and regimen must be stable for ≥12 weeks prior to Screening and during Stablization
6. Urine PCR \>1.5 g/g (\>169.5 mg/mmol) or 24-hour total protein \>1.5 g/day based on 24-hour urine collection during Screening.
7. Estimated GFR ≥25 mL/min/1.73 m2 at Screening
8. Seated blood pressure ≤160/100 mm Hg (mean of 3 values) (patients ≥18 years of age) or between the 5th and 95th percentile for age, sex, and height 29 (patients \<18 years of age) at Screening.
9. Body weight ≥35 kg (all patients) AND a BMI ≤40 kg/m2 (patients ≥18 years of age) or between the 5th and 98th percentile for age and sex (patients \<18 years of age) at Screening.
10. A female patient is eligible to participate if she is not pregnant or planning to become pregnant during the study, not breastfeeding, and at least one of the following conditions applies:
1. Is not of childbearing potential
2. If of childbearing potential and beginning at menarche, agrees to use a highly effective method of contraception consistently during the treatment period.
11. A male patient with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception
12. A patient or parent/legal guardian (as appropriate) who is capable of giving signed informed consent, and where required, the patient is capable of providing assent.

1. Has FSGS secondary to another condition.
2. History of type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (defined as glycated hemoglobin \[HbA1c\] \>8%)
3. History of lymphoma, leukemia, or any active malignancy within the past 2 years
4. Active clinically significant hepatobiliary disease.
5. Documented history of heart failure (New York Heart Association Class III/IV) or a major adverse cardiac event within 12 weeks prior to Screening.
6. Has a physical, medical, or psychological condition, that in the opinion of the Investigator, may interfere with the evaluation the study.
7. The patient has a history of alcohol or illicit drug use disorder within 1 year prior to Screening.
8. Had a prior organ transplant or stem cell transplant, with the exception of corneal transplant.
9. Positive screening assessment for viral hepatitis B surface antigen, or anti-hepatitis C virus antibody AND positive HCV RNA, or human immunodeficiency virus 1 and 2.
10. Serum potassium levels \>5.5 mmol/L at Screening.
11. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2 × upper limit of normal (ULN) at Screening
12. Treatment with immunosuppressant biological drugs, calcineurin inhibitors, cyclophosphamide, azathioprine, or mycophenolate mofetil within 12 weeks prior to Screening.
13. History of serious side effects or allergic response to an angiotensin II antagonist or has a known sensitivity to any components in the Investigational Product.
14. Unable to swallow oral medication.
15. Prior participation in any Dimerix-sponsored DMX-200 clinical study.
16. Participation in a clinical study with an Investigational Product within 28 days or 5 half-lives (whichever is longer) prior to Screening or plans to participate in another study during the course of this study.
17. Are study site personnel directly affiliated with this study and their immediate families.

Contacts and Locations

Study Contact

David Fuller

CONTACT

+61 1300 813 321

ACTION3@dimerix.com

Alisha Smith

CONTACT

+61 1300 813 321

ACTION3@dimerix.com

Principal Investigator

David Fuller

STUDY_DIRECTOR

Dimerix Bioscience Pty Ltd

Study Locations (Sites)

ACTION3 Investigational Site 4

Phoenix, Arizona, 85027

United States

ACTION3 Investigational Site 10

Northridge, California, 91324

United States

ACTION3 Investigational Site 13

Northridge, California, 91324

United States

ACTION3 Investigational Site 20

Coral Gables, Florida, 33134

United States

ACTION3 Investigational Site 1

Coral Springs, Florida, 33071

United States

ACTION3 Investigational Site 15

Evanston, Illinois, 60201

United States

ACTION 3 Investigator Site 19

Oak Brook, Illinois, 60523

United States

ACTION3 Investigational Site 8

Baltimore, Maryland, 21205

United States

ACTION3 Investigational Site 21

Springfield, Massachusetts, 01107

United States

ACTION3 Investigational Site 18

Edina, Minnesota, 55435

United States

ACTION3 Investigational Site 5

Kansas City, Missouri, 64111

United States

ACTION3 Investigational Site 17

Lincoln, Nebraska, 68510

United States

ACTION3 Investigational Site 12

Roseburg, Oregon, 97471

United States

ACTION3 Investigational Site 9

Spartanburg, South Carolina, 29306

United States

ACTION3 Investigational Site 2

Dallas, Texas, 75231

United States

ACTION3 Investigational Site 14

Dallas, Texas, 75235

United States

ACTION3 Investigational Site 3

Houston, Texas, 77054

United States

ACTION3 Investigational Site 16

Webster, Texas, 77598

United States

ACTION3 Investigational Site 7

Salt Lake City, Utah, 84115

United States

Collaborators and Investigators

Sponsor: Dimerix Bioscience Pty Ltd

David Fuller, STUDY_DIRECTOR, Dimerix Bioscience Pty Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-30

Study Completion Date2026-06

Study Record Updates

Study Start Date2022-05-30

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

FSGS