Phase 3
N=135
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]
Autosomal Dominant Polycystic Kidney Disease （ADPKD)
Bottom Line
View on ClinicalTrials.gov: NCT01280721 ↗Enrolled (actual)
135
Serious AEs
14.8%
Results posted
Jan 2019
Primary outcome: Primary: Total Kidney Volume — 1812.38; 1878.82; 1934.14; 2214.28 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tolvaptan (Drug)
- Age
- Adult · 23+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Kidney Volume |
1812.38; 1878.82; 1934.14; 2214.28 | — |
| PRIMARY Renal Function Test (eGFR) |
61.2; 56.3; 51.8; 43.5 | — |
| PRIMARY Renal Function Test (Cys-C) |
1.016; 1.114; 1.129; 1.281 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT01280721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.