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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]

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Otsuka

Status and phase

Completed
Phase 3

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Treatments

Drug: tolvaptan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01280721
JapicCTI-101362 (Other Identifier)
156-10-003

Details and patient eligibility

About

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).

Enrollment

135 patients

Sex

All

Ages

23 to 53 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

135 participants in 1 patient group

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

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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