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Kidney Week

Abstract: INFO13-SA

ARENA 2: Twice-Daily Alkalization for Primary Distal Renal Tubular Acidosis (dRTA)

Session Information

  • Informational Posters - III
    November 09, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Fluid and Electrolytes

Authors

  • Wilson, Amy C., JW Riley Hospital for Children, Indianapolis, Indiana, United States
  • Goodyer, Paul R., McGill University, Montreal, Quebec, Canada
  • D'Alessandri-Silva, Cynthia J., Connecticut Children's Medical Center, Hartford, Connecticut, United States
  • Law, Linda, Advicenne, Nïmes, France
  • Granier, Luc andre, Advicenne, Nïmes, France
  • Guittet, Catherine, Advicenne, Nïmes, France
  • Sas, David J., Mayo Clinic, Rochester, Minnesota, United States
  • Dixon, Bradley P., Children's Hospital of Colorado, Aurora, Colorado, United States
  • Laskin, Benjamin L., The Children's Hospital of Philadelphia, Bala Cynwyd, Pennsylvania, United States
  • Noone, Damien Gerard, The Hospital for Sick Children, Toronto, Ontario, Canada
  • Greenbaum, Larry A., Emory University, Atlanta, Georgia, United States
Description

ARENA 2 (Alkalization for RENal Acidosis [NCT03644706]) is a Phase 3, prospective, multicenter, double-blind, placebo-controlled, withdrawal study in patients with primary dRTA, designed to compare the efficacy of oral ADV7103 vs. placebo in preventing metabolic acidosis (serum bicarbonate levels <18 or <17mEq/L, age dependent) and hypokalemia during a 6-day, monitored, Withdrawal Period.

ARENA 2 North American sites (USA and Canada) will enroll clinically symptomatic or genetically confirmed patients diagnosed with primary dRTA currently on alkali therapy in age-based cohorts (n=40). Exclusion criteria include acquired dRTA and eGFR<60 mL/min/1.73m2. Patients >6 months to 65-years old will switch from standard of care (SoC) to ADV7103, a bid formulation of prolonged-release K+citrate granules and K+bicarbonate granules. Open-label ADV7103 will be dosed for 8-12 weeks to titrate and stabilize the dose to control metabolic acidosis. Urine and blood chemistries, patient reported outcomes (PRO) and genetic data will be collected.

All travel, clinic time and a 6-day hospital admission will be reimbursed for patients and caregivers when allowed. Enrollment opened March 2019. An optional open-label extension follows this pivotal study.

ARENA 1, an EU dRTA Phase 3 sequential study, demonstrated ADV7103 bid was statistically superior to SoC in maintaining bicarbonate plasma levels in normal ranges across all age groups in the pivotal study and data reveals levels maintained over time in the extension study.

For more information contact Linda Law: llaw@advicenne.com

Funding

  • Advicenne Pharmaceuticals