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Exploratory Study of Genetic Factors Related to the Inhibitory Effect of Tolvaptan on Increased Kidney Volume in Patients with Autosomal Dominant Polycystic Kidney Disease

Exploratory Study of Genetic Factors Related to the Inhibitory Effect of Tolvaptan on Increased Kidney Volume in Patients with Autosomal Dominant Polycystic Kidney Disease - To explore genome biomarkers for Tolvaptan efficacy in ADPKD

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000031976
Enrollment
890
Registered
2018-03-29
Start date
2018-03-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal Dominant Polycystic Kidney Disease

Interventions

None listed

Sponsors

Otsuka Pharmaceutical Co.,Ltd.
Lead Sponsor
Bioscientia Institute for Medical Diagnostics GmbH
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The clinical data and genomic variants of Patients who have completed TEMPO(Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes)3-4 Trial (Refer to ClinicalTrials.gov: NCT00428948)

Exclusion criteria

Exclusion criteria: Patients who did not participate in extension Trial(Refer to ClinicalTrials.gov:NCT01280721 or NCT01214421)

Design outcomes

Primary

MeasureTime frame
Genetic factors related to the inhibitory effect of Tolvaptan on increased kidney volume—

Secondary

MeasureTime frame
Genetic factors related to the other possible parameters of Tolvaptan efficacy.—

Countries

Japan,North America,Europe

Contacts

Public ContactTatsuki Ibuki

Otsuka Pharmaceutical Co.,Ltd. Medical Affairs

buki.Tatsuki@otsuka.jp+81-88-665-2126

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026