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]

NCT ID: NCT01280721

Last Updated: 2019-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-08-31

Brief Summary

ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).

Conditions

Autosomal Dominant Polycystic Kidney Disease （ADPKD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tolvaptan

Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.

Group Type: EXPERIMENTAL

tolvaptan

Intervention Type: DRUG

Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.

Interventions

tolvaptan

Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who participated in Trial 156-04-251 in Japan and for whom CRF collection has been completed.
• Patients who completed 3-year repeated administration and who completed the second follow-up visit or patients whose treatment with the trial drug was interupted due to pregnancy and who completed out the second follow-up visit in Trial 156-04-251.
• Patients in whom any adverse events occurring in Trial 156-04-251 were resolved orstabilized and require no further follow-up.

Exclusion Criteria

• Patients with eGFR of less than 15 mL/min/1.73 m2
• Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant
• Patients who received any investigational drug other than Tolvaptan within 30 days prior to commencement of administration of tolvaptan
• Any patients who, in the opinion of the principle investigator or subinvestigators, should not participate in the study

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 53 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chubu Region, , Japan

Chugoku Region, , Japan

Hokkaido Region, , Japan

Kanto Region, , Japan

Kinki Region, , Japan

Kyushu Region, , Japan

Tohoku Region, , Japan

Countries

Japan

References

Muto S, Okada T, Yasuda M, Tsubouchi H, Nakajima K, Horie S. Long-term safety profile of tolvaptan in autosomal dominant polycystic kidney disease patients: TEMPO Extension Japan Trial. Drug Healthc Patient Saf. 2017 Oct 25;9:93-104. doi: 10.2147/DHPS.S142825. eCollection 2017.

Reference Type: DERIVED

PMID: 29123425 (View on PubMed)

Other Identifiers

JapicCTI-101362

Identifier Type: OTHER

Identifier Source: secondary_id

156-10-003

Identifier Type: -

Identifier Source: org_study_id