Last updated 14 months ago

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

286 patients around the world

Available in Argentina, United States, Brazil, Spain

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 duration of the double-blind period per patient is estimated to be maximum of 122 weeks, a Screening and Qualification period of between 6 and 14 weeks (including a 4 week period to complete the assessments required for Screening, Titration (if required, up to 4 weeks) and, 6-weeks of Stabilization, a 104-week Treatment period, and up to a 4-week off-treatment Follow-up period. The treatment duration of the OLE period per patient is estimated to be a minimum of 104 weeks (2 years) with a 4-week off-treatment Follow-up period. The total study duration (double-blind period and OLE combined) is currently estimated to be a minimum of 230 weeks.

Dimerix Bioscience Pty Ltd

286Patients around the world

This study is for people with

Glomerulonephritis

Focal segmental glomerulosclerosis

Requirements for the patient

To 80 Years

All Gender

Medical requirements

: Patients must be 12 to 80 years old
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
Must be either receiving an ARB at the maximal tolerated dose or willing to transition
If taking corticosteroids, the dosage must be stable for ≥4 weeks prior to Screening and during Stablization
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
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.
Estimated GFR ≥25 mL/min/1.73 m2 at Screening
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.
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.
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:
Is not of childbearing potential
If of childbearing potential and beginning at menarche, agrees to use a highly effective method of contraception consistently during the treatment period.
A male patient with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception
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.

: Has FSGS secondary to another condition.
History of type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (defined as glycated hemoglobin [HbA1c] >8%)
History of lymphoma, leukemia, or any active malignancy within the past 2 years
Active clinically significant hepatobiliary disease.
Documented history of heart failure (New York Heart Association Class III/IV) or a major adverse cardiac event within 12 weeks prior to Screening.
Has a physical, medical, or psychological condition, that in the opinion of the Investigator, may interfere with the evaluation the study.
The patient has a history of alcohol or illicit drug use disorder within 1 year prior to Screening.
Had a prior organ transplant or stem cell transplant, with the exception of corneal transplant.
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.
Serum potassium levels >5.5 mmol/L at Screening.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 × upper limit of normal (ULN) at Screening
Treatment with immunosuppressant biological drugs, calcineurin inhibitors, cyclophosphamide, azathioprine, or mycophenolate mofetil within 12 weeks prior to Screening.
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.
Unable to swallow oral medication.
Prior participation in any Dimerix-sponsored DMX-200 clinical study.
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.
Are study site personnel directly affiliated with this study and their immediate families.

StudyACTION3

SponsorDimerix Bioscience Pty Ltd

Study typeInterventional

Conditions

Focal segmental glomerulosclerosis

Requirements

To 80 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05183646