ARENA2 is a pivotal Phase III, prospective, multicenter, randomized, double-blind, placebo-controlled clinical study that is expected to include approximately 40 patients in the United States and Canada. The principal objective of the clinical study is to evaluate the safety and efficacy of ADV7103 versus placebo in preventing the development of metabolic acidosis in patients with primary dRTA.
ARENA2 will be ready for patient entry in June 2021 and will imply a COVID-19 friendly protocol requiring no hospitalizations. ARENA2 was initiated following the European ARENA1 study that showed positive results with ADV7103 after 24 months of treatment and resulting in EU wide marketing approval for ADV7103 / Sibnayal®.
ARENA2 is a 12 week, randomized withdrawal virtual study design. Home visits by a specialized trained nurse allow for subjects to have the majority of tests in their home. The virtual study platform also enables you to hold patient visits via a compliant telemedicine portal, in-person in the outpatient setting, or a mix of both as deemed appropriate.
ADV7103 is an investigational oral medication designed to treat primary distal renal tubular acidosis (dRTA) in patients 6 months to 65 years of age. ADV7103 sachet packets contain 2mm granules of potassium bicarbonate and potassium citrate. The medication is designed to be taken twice a day and studies have shown that ADV7103 is tasteless and has less gastrointestinal side effects than current standard of care. Patients of all ages can take this medication and it may be put in yogurt or pudding for smaller children.
For more information on the study please go to Clinicaltrials.gov
ADV7103 – Mechanism of Action
Study Flyer for HCPs (direct download)MD-Referral-Flyer-FINAL-2
European Study Publication (download link)
dRTA Communities and Resources
Since its founding in 2007, Advicenne has been dedicated to developing and commercializing innovative treatments that address unmet medical needs in the area of nephrology. Our lead drug candidate, ADV7103, is in late-stage clinical trials for two indications: distal renal tubular acidosis (dRTA) and cystinuria. Listed on both the Euronext Paris and Euronext Brussels stock exchanges, the company is headquartered in Nîmes, France.
You are not alone. Connect with other members of the dRTA community on social media and with organizations providing education and support.
ADV7103 is an investigational product and has not been demonstrated to be safe and effective in the US population.