*ACTION3
Research type
Research Study
Full 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)
IRAS ID
1004525
Contact name
Robert Shepherd
Contact email
Eudract number
2021-004174-64
ISRCTN Number
ISRCTN72772236
Clinicaltrials.gov Identifier
Research summary
Focal segmental glomerulosclerosis (FSGS) is a histologic injury of the filtering part of the kidneys (glomerulus). FSGS is a progressive kidney disease where the filters (glomeruli) of the kidneys become more ‘leaky’ and allows protein from the blood to collect in the urine (proteinuria). The kidneys' ability to clean the blood is impaired which can lead to kidney failure. FSGS is routinely treated with a type of drug called angiotensin II receptor blocker (ARB).
The purpose of this study, funded by Dimerix Bioscience Pty Ltd, is to assess the safety and efficacy (how well a drug works) of a new drug called DMX-200 (repagermanium) in adult patients with FSGS, who are being treated with an ARB. DMX-200 is designed to inhibit the inflammatory response of chronic disease, including FSGS, when given alongside an ARB.
This Study will investigate to see if the study drug, DMX-200 (repagermanium), reduces the amount of proteinuria and slows the decline of kidney function, when taken with an ARB.
This study is recruiting participants between the ages of 18 to 80 years old with a confirmed diagnosis by kidney biopsy of FSGS. Approximately 286 participants will be recruited worldwide at around 167 study sites.
The study consists of five periods:
1. Screening period (up-to 4-weeks), to check that participants qualify for the study.
2. Titration period (up to 4-weeks), required for participants who are not already receiving an ARB treatment at the maximum tolerated dose.
3. Stabilisation period (6 weeks), to check participants remain eligible.
4. Double-blind treatment period (104-weeks), where all participants will be randomly assigned to receive either the study drug or placebo (50/50 chance). A placebo looks like a medicine but does not have any medicine in it.
5. Follow-up period (4 weeks), for post-treatment safety investigations.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
22/EM/0181
Date of REC Opinion
8 Mar 2022
REC opinion
Further Information Favourable Opinion