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) - ACTION3

Dimerix Bioscience Pty Ltd0 sites286 target enrollmentDecember 22, 2021

ConditionsFocal segmental glomerulosclerosis MedDRA version: 21.1Level: PTClassification code 10067757Term: Focal segmental glomerulosclerosisSystem Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1Level: LLTClassification code 10016832Term: Focal & segmental glomerulosclerosisSystem Organ Class: 10038359 - Renal and urinary disorders Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Focal segmental glomerulosclerosis
Sponsor: Dimerix Bioscience Pty Ltd
Enrollment: 286
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 22, 2021

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Dimerix Bioscience Pty Ltd

Eligibility Criteria

Inclusion Criteria

•Key Inclusion Criteria:
•\- A diagnosis of FSGS confirmed by kidney biopsy. NOTE: The biopsy can have been obtained at any time. Diagnosis of FSGS should be based on light microscopy with supportive findings on either electron microscopy or immunofluorescence analysis (preferably both) and the clinical history and disease course consistent with primary FSGS, genetic FSGS, or FSGS of undetermined cause.
•\- Must be receiving a stable dose of an ARB (irbesartan, losartan, valsartan, candesartan, olmesartan medoxomil, or azilsartan medoxomil) at the maximal tolerated dose and \=50% of the maximum recommended dose per the product label for 6 weeks prior to Screening, or willing to transition to this treatment during the Titration and Stabilization period.
•\- If taking corticosteroids, the dosage must be stable for \=4 weeks prior to Screening and during the Stabilization period, and patients must have no plan to change their treatment regimen during the study.
•\- If taking aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, or sodium\-glucose co\-transporter\-2 inhibitors, the dose and regimen must be stable for \=26 weeks prior to Screening and during the Stabilization period and patients must have no plan to change their treatment regimen during the study.
•\- Urine protein/creatinine ratio (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 glomerular filtration rate (eGFR) \=30 mL/min/1\.73 m2 at Screening and \=25 mL/min/1\.73 m2 at the Qualification visit (Week \-1\).
•\- Seated blood pressure \=160/100 mm Hg (mean of 3 values) at Screening and \=140/90 mm Hg (mean of 3 values) at the Qualification visit (Week \-1\).
•\- Body mass index \=40 kg/m2 at Screening.
•Are the trial subjects under 18? no

Exclusion Criteria

•Key Exclusion Criteria:
•\- Has FSGS secondary to another condition.
•\- History of type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (defined as glycated hemoglobin \>8%), or non\-fasting blood glucose \>10 mmol/L at Screening.
•\- History of lymphoma, leukemia, or any active malignancy within the past 2 years (except for basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ that have been resected and with no evidence of metastatic disease).
•\- History of jaundice, active hepatitis, or known hepatobiliary disease (except asymptomatic cholelithiasis).
•\- Documented history of heart failure (New York Heart Association Class III/IV) or a major adverse cardiac event within 12 weeks prior to Screening.
•\- Serum potassium levels \>5\.5 mmol/L at Screening.
•\- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2 × upper limit of normal at Screening.
•\- Treatment with immunosuppressant biological drugs, calcineurin inhibitors, cyclophosphamide, azathioprine, or mycophenolate mofetil within 26 weeks prior to Screening
•\- Patients with \<80\.0% compliance to ARB treatment during the Stabilization Period (Weeks \-6 to \-1\) of the study, as confirmed at the Qualification visit.