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)

Dimerix Bioscience Pty Ltd0 sites286 target enrollmentJanuary 20, 2022

ConditionsFocal segmental glomerulosclerosis (FSGS)Renal and Urogenital - Kidney disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Focal segmental glomerulosclerosis (FSGS)
Sponsor: Dimerix Bioscience Pty Ltd
Enrollment: 286
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 20, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Dimerix Bioscience Pty Ltd

Eligibility Criteria

Inclusion Criteria

•DOUBLE BLIND PERIOD
•1\. Patients must be 12 to 80 years old (adolescents will only be recruited in Argentina, Mexico, UK, US).
•2\. A diagnosis of primary FSGS, genetic FSGS, or FSGS of undetermined cause.
•4\. If taking corticosteroids, the dosage must be stable for greater than or equal to 4 weeks prior to Screening and during Stabilization.
•5\. If taking aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, or sodium\-glucose co\-transporter\-2 (SGLT2\) inhibitors, or endothelin receptor antagonists (ERAs, including dual antagonists), the dose and regimen must be stable for greater than or equal to 12 weeks prior to Screening and during Stabilization.
•7\. Estimated GFR
•8\. Seated blood pressure less than or equal to 160/100 mm Hg (mean of 3 values) (patients greater than or equal to 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 greater than or equal to 35 kg (all patients) AND a BMI less than or equal to 40 kg/m2 (patients greater than or equal to 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:
•b. Is of childbearing potential and beginning at menarche, agrees to use a highly effective method of contraception consistently during the treatment period.

Exclusion Criteria

•DOUBLE\-BLIND PERIOD
•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\.