NCT03831152

Extension Study in Primary Distal Renal Tubular Acidosis

A Phase 3B Open-Label Extension Of Study B23CS (ARENA 2) Evaluating The Continued Safety And Efficacy Of ADV7103 In Subjects With Primary Distal Renal Tubular Acidosis

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Advicenne Pharma · Industry
• Sex: All
• Age: 4 Months – 65 Years
• Healthy volunteers: Not accepted

Summary

Open-label study involving longitudinal assessment of the continued safety, tolerability, and efficacy of ADV7103 in maintaining targeted serum bicarbonate levels, preventing metabolic acidosis, and preventing hypokalemia in the following groups of subjects with primary dRTA: 1. subjects who participated in Study B23CS and were adherent to the protocol; 2. subjects ≥ 6 months of age who are living in Europe and did not participate in Study B23CS; and 3. infants younger than 6 months of age

Conditions

• Acidosis, Renal Tubular

Interventions

Type	Name	Description
DRUG	ADV7103	Single group assignment

Timeline

• Start date: 2023-12-20
• Primary completion: 2025-01-01
• Completion: 2025-03-01
• First posted: 2019-02-05
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study