Phase 3
Completed 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)
Source: ClinicalTrials.gov NCT01280721 ↗
Enrolled (actual)
135
Serious AEs
14.8%
Results posted
Jan 2019
Primary outcomePrimary: Total Kidney Volume — 1812.38; 1878.82; 1934.14; 2214.28 mL
◆ Published Evidence
Emerging
19citations · ~2 / year
Long-term safety profile of tolvaptan in autosomal dominant polycystic kidney disease patients: TEMPO Extension Japan Trial.
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).
Linked Publications
-
Long-term safety profile of tolvaptan in autosomal dominant polycystic kidney disease patients: TEMPO Extension Japan Trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.