Clinical Trial: Extension Study in Primary Distal Renal Tubular Acidosis
Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
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
Brief 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:
- subjects who participated in Study B23CS and were adherent to the protocol;
- subjects ? 6 months of age who are living in Europe and did not participate in Study B23CS; and
- infants younger than 6 months of age
Detailed Summary:
Sponsor: Advicenne Pharma
Current Primary Outcome: Number/proportion of subjects presenting with ADV7103 treatment-related adverse events (AEs) during the study, by severity grade.
Original Primary Outcome: Number/proportion of subjects presenting with ADV7103 treatment-related adverse events (AEs) during the study, by severity grade.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Advicenne Pharma
Dates:
Date Received: January 23, 2019
Date Started: December 01, 2023
Date Completion: December 01, 2023
Last Updated: May 08, 2023
Last Verified: May 01, 2023
