05 Oct HERA Interventional Clinical Study
Regulus Therapeutics is pleased to announce the initiation of the HERA study, an interventional clinical study in Alport syndrome patients. The purpose of this research study is to evaluate the safety and effectiveness of an investigational drug (an anti-microRNA 21 called RG-012) compared to placebo as a treatment for patients with Alport syndrome.
Alport syndrome patients are eligible to volunteer for this study if they are between the ages of 18-65 years, and have a diagnosis of Alport syndrome. Other study eligibility requirements include: adequate rate of GFR decline over time, elevated proteinuria, and a stable regimen of an ACE inhibitor or ARB. The study includes a screening period of 12-24 weeks, and study visits for up to 36 weeks.
The study treatment will be assigned randomly with two-thirds of the participants assigned to RG-012 (either Treatment A or Treatment B) and the other one-third to placebo. Neither the participant nor the study doctor will know what study treatment has been assigned. Patients will receive weekly study drug injections (RG-012 or placebo) for 24 weeks. Patients that complete 24 weeks of treatment may be asked to participate in an extension study where all participants receive RG-012. Some visits will require coming to the study doctor’s clinic; for some visits patients will be offered the option to have a study nurse come to a specified location. Travel and lodging assistance is available at most sites.
The study is currently open for enrollment in California and New York; additional sites in the United States, Canada, Germany, France, Spain, United Kingdom and Australia will open soon.
For patients currently participating in the ATHENA Natural History study, your study site will contact you once the site is activated on the HERA study if you meet the eligibility criteria.
** This was originally shared via email.
Please see the study update dated 11-18-16.