drugset
drugset / Trial / NCT03949894

Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease

NCT03949894 ↗

Phase 4 Completed 118 enrolled Korea Otsuka Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

To evaluate the safety and therapeutic effectiveness of tolvaptan when administered to slow the progression of cyst development and renal function insufficiency in adult Korean patients diagnosed with rapidly progressive ADPKD who have chronic kidney disease (CKD) stages 1-3 at initiation of treatment.

Timeline

Start
2019-07-01
Primary completion
2022-05-25
Completion
2022-05-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolvaptan Small molecule 15 mg —
Subject Tolvaptan Small molecule 30 mg —

Indications

autosomal dominant polycystic kidney disease