Trial Profile

A Phase 3 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Withdrawal Study Evaluating ADV7103 In Pediatric and Adult Subjects With Distal Renal Tubular Acidosis (dRTA)

Status: Discontinued

Phase of Trial: Phase III

Latest Information Update: 10 Jun 2026

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At a glance

03 Jun 2026 Primary endpoint revised from mean change in blood bicarbonate levels for prevention of metabolic acidosis (based on consecutive serum bicarbonate thresholds) to change in blood bicarbonate levels during the withdrawal period, calculated as Day 6 minus Day 1 bicarbonate levels.
08 Mar 2024 Status changed from not yet recruiting to discontinued. Reason for discontinuation: The study design needs to be reviewed due to challenge of exposing subjects to rebound metabolic acidosis on placebo arm. New design is under discussion with FDA.
08 May 2023 Planned End Date changed from 1 Aug 2022 to 1 Oct 2024.

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