Biopharmaceutical company Dimerix Limited (ASX: DXB) has entered into a collaboration with the UK’s National Registry of Rare Kidney Diseases (RaDaR) to prospectively identify suitable FSGS patients for the ACTION3 Phase 3 clinical trial.
RaDaR is a UK Kidney Association initiative, led by Professor Danny Gale from University College London, and is designed to collate information across patients diagnosed with certain rare kidney diseases, including FSGS.
RaDaR is the largest, rare kidney disease registry in the world and holds records of over 34,500 rare kidney disease patients recruited from 109 hospitals across the UK. RaDaR is run by the UK Kidney Association and was established with funding from the Medical Research Council, Kidney Research UK, Kidney Care UK, and the Polycystic Kidney Disease Charity.
Under terms of the collaboration, RaDaR will identify UK patients with FSGS who meet the ACTION3 Phase 3 clinical trial inclusion criteria. RaDaR staff will then contact these patients and provide those that express interest in participation with contact details for their closest ACTION3 clinical trial site. Dimerix believes this collaboration will further enhance the recruitment rates in the UK for its ACTION3 Phase 3 clinical trial.
“We are very pleased to be working with RaDaR on this collaboration, as it represents a unique way to connect with FSGS patients across the United Kingdom for potential trial participation," Chief Medical Officer, Dr David Fuller, said.
"The UK has an excellent renal research infrastructure and RaDaR has a strong track record of assisting companies who are working towards bringing new treatments for rare renal diseases, such as FSGS, recruit patients.”
The ACTION3 clinical trial is currently recruiting across 16 of the 19 planned countries. The full study recruitment target is 286 patients. Regulatory agencies in different parts of the world often have different regulatory and ethics requirements for opening clinical sites, hence the opening of clinical sites is often staggered from country to country.
Pleasingly, Dimerix also received approval for its Investigational New Drug Application (IND), which is a prerequisite for trial initiation, from the Thai Food and Drug Administration (FDA) this week and expects clinical sites to initiate recruitment in Thailand in the coming weeks.
“Data from the RaDaR registry show that people with rare kidney diseases such as FSGS have a substantially higher risk of needing treatment for kidney failure than do other people in the population with chronic kidney disease," Professor Daniel Gale, Professor of Nephrology UCL Department of Renal Medicine; Chair UK Rare Diseases Committee UK Kidney Association.
“Many patients who participate in RaDaR are aware of this and are interested in finding more about participating in research trials that might help to address this important area of unmet medical needed.
“We are therefore very happy to be able to work with Dimerix to contact RaDaR participants who might be eligible for their Phase 3 study in FSGS to help them to find out about this study and decide whether to participate in it.”
The Phase 3 study, which is titled “Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis”, or ACTION3 for short, is a pivotal (Phase 3), multi-centre, randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients will be randomized to receive either DMX200 (120 mg capsule twice daily) or placebo.
The single Phase 3 trial in FSGS patients will follow 286 patients across 2 years, with a further blinded interim analysis built in which is planned after the first 144 patients reach 35 weeks of treatment, designed to capture evidence of proteinuria and kidney function (eGFR slope) during the trial, aimed at generating sufficient evidence to support marketing approval.
