Extension Study in Primary Distal Renal Tubular Acidosis

Acidosis, Renal Tubular Clinical Trial

Official title: 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Status Withdrawn

Clinical Trial 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

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Acidosis
• Acidosis, Renal Tubular

• NCT number: NCT03831152
• Study type: Interventional
• Source: Advicenne Pharma
• Status: Withdrawn
• Phase: Phase 3
• Start date: December 20, 2023
• Completion date: March 2025