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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05183646




Registration number
NCT05183646
Ethics application status
Date submitted
29/11/2021
Date registered
10/01/2022

Titles & IDs
Public title
A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB
Scientific 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)
Secondary ID [1] 0 0
DMX-200-301
Universal Trial Number (UTN)
Trial acronym
ACTION3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
FSGS 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DMX-200
Treatment: Drugs - Placebo

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


Treatment: Drugs: DMX-200
DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor.

Treatment: Drugs: Placebo
Patients will receive 120 mg capsules of Placebo twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the efficacy of DMX-200 in terms of urine PCR in patients with FSGS who are receiving an ARB.
Timepoint [1] 0 0
Baseline to Week 35
Primary outcome [2] 0 0
Evaluate the efficacy of DMX-200 in terms of eGFR slope in patients with FSGS who are receiving an ARB (Analysis at week 35 and Week 104).
Timepoint [2] 0 0
Baseline to Week 104
Primary outcome [3] 0 0
OLE - Assess the long-term safety and tolerability of open-label treatment with DMX-200 in patients with FSGS who are receiving an ARB.
Timepoint [3] 0 0
Double-blind baseline to Week 216
Secondary outcome [1] 0 0
Evaluate the incidence and severity of AEs with treatment of DMX-200 in patients with FSGS who are receiving an ARB.
Timepoint [1] 0 0
Baseline to Week 104
Secondary outcome [2] 0 0
To evaluate the effect of DMX-200 on kidney function parameters including proteinuria in patients with FSGS who are receiving an ARB.
Timepoint [2] 0 0
Baseline to Week 104
Secondary outcome [3] 0 0
OLE - Assess the long-term efficacy of open-label treatment with DMX-200 in patients with FSGS who are receiving an ARB.
Timepoint [3] 0 0
From Week 108 (Baseline) at each visit
Secondary outcome [4] 0 0
OLE - Evaluate the long-term effect of open-label treatment with DMX-200 on kidney function parameters in patients with FSGS who are receiving an ARB.
Timepoint [4] 0 0
Double blind baseline to Week 216

Eligibility
Key inclusion criteria
DOUBLE BLIND PERIOD



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.
Minimum age
12 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

OLE PERIOD

Inclusion Criteria:

1. 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.
2. Patients who have completed participation in the double-blind period, including the Week 104 visit, and who may derive benefit from (continued) treatment with DMX-200, and/or continued follow-up
3. The patient received blinded Investigational Product throughout the duration of the double-blind period up to the Week 104 visit
4. The patient continues to meet the contraceptive requirements



1. The patient has met the criteria for permanent IP discontinuation or study discontinuation
2. Any safety concerns identified during the double-blind period which, in the Investigator's opinion, may interfere with the patient's continued participation during the OLE period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
286
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
ACTION3 Investigational Site 1 - Brisbane
Recruitment hospital [2] 0 0
ACTION3 Investigational Site 2 - Melbourne
Recruitment hospital [3] 0 0
Action3 Investigator Site 6 - Melbourne
Recruitment hospital [4] 0 0
ACTION3 Investigational Site 4 - Sydney
Recruitment hospital [5] 0 0
ACTION3 Investigational Site 5 - Sydney
Recruitment hospital [6] 0 0
ACTION3 Investigational Site 7 - Sydney
Recruitment hospital [7] 0 0
Action3 Investigator Site 3 - Sydney
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Ciudad Autonoma Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Córdoba
Country [17] 0 0
Argentina
State/province [17] 0 0
Santa Fe
Country [18] 0 0
Brazil
State/province [18] 0 0
Botucatu
Country [19] 0 0
Brazil
State/province [19] 0 0
Recife
Country [20] 0 0
Brazil
State/province [20] 0 0
Rio De Janeiro
Country [21] 0 0
Brazil
State/province [21] 0 0
São Paulo
Country [22] 0 0
Denmark
State/province [22] 0 0
Copenhagen
Country [23] 0 0
Denmark
State/province [23] 0 0
Kolding
Country [24] 0 0
Denmark
State/province [24] 0 0
Odense
Country [25] 0 0
France
State/province [25] 0 0
Gironde
Country [26] 0 0
France
State/province [26] 0 0
Créteil
Country [27] 0 0
France
State/province [27] 0 0
Grenoble
Country [28] 0 0
France
State/province [28] 0 0
Marseille
Country [29] 0 0
France
State/province [29] 0 0
Montpellier
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
France
State/province [31] 0 0
Saint-Priest-en-Jarez
Country [32] 0 0
Hong Kong
State/province [32] 0 0
Hong Kong
Country [33] 0 0
New Zealand
State/province [33] 0 0
Auckland
Country [34] 0 0
New Zealand
State/province [34] 0 0
Hamilton
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Córdoba
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Sevilla
Country [39] 0 0
Taiwan
State/province [39] 0 0
Kaohsiung
Country [40] 0 0
Taiwan
State/province [40] 0 0
New Taipei City
Country [41] 0 0
Taiwan
State/province [41] 0 0
Taichung
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taipei CITY
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taipei
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Carshalton
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Glasgow
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Leicester
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Dimerix Bioscience Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Fuller
Address 0 0
Dimerix Bioscience Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David Fuller
Address 0 0
Country 0 0
Phone 0 0
+61 1300 813 321
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05183646