Abstract: INFO21
ARENA2: Decentralized Clinical Trial for Patients With Primary Distal Renal Tubular Acidosis (dRTA)
Session Information
- Informational Posters
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Fluid, Electrolyte, and Acid-Base Disorders
- No subcategory defined
Authors
- Wilson, Amy C., Riley Hospital for Children at Indiana University Health, Indianapolis, Indiana, United States
- Goodyer, Paul R., McGill University, Montreal, Quebec, Canada
- Panzarino, Valerie Marie, University of South Florida, Tampa, Florida, United States
- D'Alessandri-Silva, Cynthia J., Connecticut Children's Medical Center, Hartford, Connecticut, United States
- Sas, David J., Mayo Clinic Minnesota, Rochester, Minnesota, United States
- Dixon, Bradley P., University of Colorado Health, Aurora, Colorado, United States
- Laskin, Benjamin L., The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
- Noone, Damien Gerard, The Hospital for Sick Children, Toronto, Ontario, Canada
- Alexander, R. Todd, Edmonton Clinic Health Academy, Edmonton, Alberta, Canada
- Ogg, Carol, Advicenne, Inc, ATLANTA, Georgia, United States
- Greenbaum, Larry A., Emory University, Atlanta, Georgia, United States
Description
ARENA2 (Alkalization for RENal Acidosis) is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in patients with primary dRTA (NCT03644706), designed to compare the efficacy of oral ADV7103 vs. placebo in preventing metabolic acidosis and hypokalemia, followed by an optional open-label extension.
ADV7103 is an innovative, prolonged-release oral granule combining the advantages of potassium citrate and potassium bicarbonate with twice daily dosing eliminating the addition of extra sodium. The European ARENA1 program previously demonstrated ADV7103 was superior to standard of care (SoC) in maintaining bicarbonate plasma levels in normal ranges across all age groups in patients with dRTA and levels were maintained over time resulting in approval of ADV7013 (Sibnayal™) by the EMA.
North American sites (USA and Canada) will enroll patients with a clinical diagnosis of primary dRTA, requiring > 0.9 mEq/kg/day of alkali therapy, in age-based cohorts (n=40). Exclusion criteria include acquired/secondary dRTA, eGFR<60 mL/min/1.73m2, and evidence of proximal tubule dysfunction. Patients 6 months to 65-years old will switch from SoC to ADV7103. Twice daily ADV7103 administration will be titrated and stabilized for 8-12 weeks to determine the dose necessary to control metabolic acidosis. Patients will then be randomized to ADV7103 or placebo and monitored for up to 6-days in period 3. The primary endpoint will compare the efficacy of ADV7103 versus placebo in preventing metabolic acidosis, defined as two consecutive serum bicarbonate levels <18 mEq/L for subjects >4 years old and <17 mEq/L for subjects <4 years during the withdrawal period. The study will include longitudinal monitoring of urine and blood chemistries and patient reported outcomes (PRO).
Due to COVID-19, the ARENA2 protocol has been revised to accommodate a decentralized and virtual study design allowing patients the flexibility to participate from home utilizing home-care nursing services. Enrollment will open July 2021.
Contact Larry Greenbaum at lgreen6@emory.edu.
Funding
- Advicenne, Inc.