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Tolvaptan (OPC-41061)

DRUG2 trials

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

Conditions

Autosomal Dominant Polycystic Kidney DiseaseAutosomal Recessive Polycystic Kidney Disease (ARPKD)Chronic Kidney Disease

Phase 3

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 Disease
CompletedNCT02160145
Otsuka Pharmaceutical Development & Commercialization, Inc.Autosomal Dominant Polycystic Kidney Disease, Chronic Kidney Disease
Start: 2014-05-31End: 2017-04-18Updated: 2018-08-08
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)
WithdrawnNCT04786574
Otsuka Pharmaceutical Development & Commercialization, Inc.Autosomal Recessive Polycystic Kidney Disease (ARPKD)
Start: 2022-07-01End: 2025-12-10Updated: 2025-12-24

Related Papers

Effects of tolvaptan discontinuation in patients with autosomal dominant polycystic kidney disease: a post hoc pooled analysis.
2023-06-221 citations
Tolvaptan and Kidney Function Decline in Older Individuals With Autosomal Dominant Polycystic Kidney Disease: A Pooled Analysis of Randomized Clinical Trials and Observational Studies.
2023-04-1410 citations
OVERTURE: A Worldwide, Prospective, Observational Study of Disease Characteristics in Patients With ADPKD.
2023-02-1321 citations
Design of two ongoing clinical trials of tolvaptan in the treatment of pediatric patients with autosomal recessive polycystic kidney disease.
2023-02-138 citations
Clinical Pattern of Tolvaptan-Associated Liver Injury in Trial Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD): An Analysis of Pivotal Clinical Trials.
2022-09-3022 citations
Tolvaptan in ADPKD Patients With Very Low Kidney Function.
2021-06-0917 citations
Effect of tolvaptan in Japanese patients with autosomal dominant polycystic kidney disease: a post hoc analysis of TEMPO 3:4 and TEMPO Extension Japan
Clinical and Experimental Nephrology2021-06-0410 citations
Per-Treatment <i>Post Hoc</i> Analysis of Clinical Trial Outcomes With Tolvaptan in ADPKD.
2021-02-02
P0680A POST-HOC ANALYSIS OF EFFICACY AND SAFETY OF TOLVAPTAN (TOL) IN DECREASING RATE OF RENAL FUNCTION DECLINE IN PATIENTS WITH VERY LATE-STAGE AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
Nephrology Dialysis Transplantation2020-06-01
A Post Hoc Analysis of Statin Use in Tolvaptan Autosomal Dominant Polycystic Kidney Disease Pivotal Trials
Clinical Journal of the American Society of Nephrology2020-04-0214 citations
SAT-447 PER TREATMENT POST-HOC ANALYSIS OF CLINICAL TRIAL OUTCOMES WITH TOLVAPTAN (TLV) IN AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
Kidney International Reports2020-03-01
Modelling the long-term benefits of tolvaptan therapy on renal function decline in autosomal dominant polycystic kidney disease: an exploratory analysis using the ADPKD outcomes model.
2019-04-2312 citations
Tolvaptan in Later-Stage Autosomal Dominant Polycystic Kidney Disease
New England Journal of Medicine2017-11-04578 citations
REPRISE 3b Study in Enrollment Phase
MD Conference Express2015-01-01