Otsuka Holdings Co., Ltd.: Polycystic Kidney Diseases trials

The registry lists 16 Polycystic Kidney Diseases studies with Otsuka Holdings Co., Ltd. as lead sponsor. 1 are open to participants now and 12 have results posted.

Phase 2 5Phase 3 9Phase 4 1No phase 1(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.

• A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)RecruitingNCT04782258Phase 3
• Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)CompletedNCT02964273Phase 3Results 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
• A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)WithdrawnNCT04786574Phase 3
• Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney DiseaseCompletedNCT03949894Phase 4
• A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in EuropeStatus unknownNCT02848521