Otsuka Holdings Co., Ltd.: Polycystic Kidney, Autosomal Dominant trials

The registry lists 17 Polycystic Kidney, Autosomal Dominant studies with Otsuka Holdings Co., Ltd. as lead sponsor. 0 are open to participants now and 13 have results posted.

Phase 2 5Phase 3 7Phase 4 1No phase 4(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)CompletedNCT02964273Phase 3Results posted
• Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKDCompletedNCT02847624Results posted
• Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney DiseaseCompletedNCT02251275Phase 3Results posted
• Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney DiseaseCompletedNCT02160145Phase 3Results posted
• 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)CompletedNCT01451827Phase 2Results posted
• Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)CompletedNCT01336972Phase 2Results posted
• A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]CompletedNCT01280721Phase 3Results posted
• Tolvaptan Extension Study in Participants With ADPKDCompletedNCT01214421Phase 3Results posted
• Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKDCompletedNCT01210560Phase 2Results posted
• A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]CompletedNCT01022424Phase 3Results posted
• A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]CompletedNCT00841568Phase 2Results posted
• Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)CompletedNCT00428948Phase 3Results posted
• Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)CompletedNCT00413777Phase 2Results posted
• Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney DiseaseCompletedNCT03949894Phase 4
• Canadian Medical Assessment of JINARC™ Outcomes RegistryCompletedNCT02925221
• A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in EuropeStatus unknownNCT02848521
• Observational Study in Patients With Autosomal Dominant Polycystic Kidney DiseaseCompletedNCT01430494