drugset / Trial / NCT03644706
Study Evaluating Subjects With Distal Renal Tubular Acidosis
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a phase 3, prospective, multicenter, randomized, double-blinded, placebo-controlled withdrawal study comparing the efficacy of ADV7103 versus placebo in preventing the development of metabolic acidosis in pediatric and adult subjects with primary Distal Renal Tubular Acidosis (dRTA).
Timeline
- Start
- 2021-09-20
- Primary completion
- 2023-12-20
- Completion
- 2023-12-20
Outcome
Outcome not reported
Stopped (Enrollment): “COVID-19 pandemic negatively impacted the ability to enroll patients.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ADV7103 | Unknown | — | — |