Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD
NCT ID: NCT02847624
Last Updated: 2025-12-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1802 participants
OBSERVATIONAL
2014-03-24
2022-09-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tolvaptan-Octreotide LAR Combination in ADPKD
NCT03541447
Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
NCT01336972
Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease
NCT03596957
Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD
NCT03803124
Dietary Intervention in ADPKD on Tolvaptan
NCT03858439
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ADPKD
tolvaptan
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
tolvaptan
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* total kidney volume of 750 or more
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yasuhiko Fukuta, PhD
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Co., Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Otsuka Pharmaceutical Co., Ltd.
Tokyo, , Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Mochizuki T, Muto S, Suzue K, Komaniwa S, Tanaka T, Fukuta Y, Yamashige Y. Safety and efficacy of tolvaptan in real-world Japanese patients with autosomal dominant polycystic kidney disease: final results of SLOW-PKD surveillance. Clin Exp Nephrol. 2025 Jun;29(6):807-817. doi: 10.1007/s10157-025-02634-7. Epub 2025 Feb 14.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15600-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.