drugset / Trial / NCT03644706

Study Evaluating Subjects With Distal Renal Tubular Acidosis

NCT03644706 ↗

Phase 3 Terminated 3 enrolled Advicenne Pharma
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

EvaluationDrugModalityDoseRoute
Comparator ADV7103 Unknown — —