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: 22 Mar 2024
Price :
$35
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At a glance
- Drugs Potassium bicarbonate/potassium citrate (Primary)
- Indications Renal tubular acidosis
- Focus Registrational; Therapeutic Use
- Acronyms ARENA-2
- Sponsors Advicenne
- 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.
- 08 May 2023 Planned primary completion date changed from 1 Apr 2022 to 1 Aug 2024.