Extension Study in Primary Distal Renal Tubular Acidosis

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

Timeline

Start

2023-12-20

Primary completion

2025-01

Completion

2025-03

Outcome

Outcome not reported

Stopped (Enrollment): “No patients enrolled. Study no longer required due to completion of long term safety study in the EU.”

Drugs

Indications