N/A
Completed N=1,802
Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD
Polycystic Kidney, Autosomal Dominant
Source: ClinicalTrials.gov NCT02847624 ↗
Enrolled (actual)
1,802
Serious AEs
15.1%
Results posted
Dec 2025
Primary outcomePrimary: Estimated Slope of Total Kidney Volume During Pre-administration and Administration — 6.7517; 3.6811 %/year
Summary
The purpose of this study is to evaluate the safety and effectiveness of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) in the real world clinical setting in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Slope of Total Kidney Volume During Pre-administration and Administration |
6.7517; 3.6811 | — |
| SECONDARY The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) |
1672; 1210; 1007; 706; 402; 47 | — |
| SECONDARY The Number of Cases in Which AST Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) |
1672; 1232; 1027; 715; 413; 47 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosed ADPKD
- total kidney volume of 750 or more
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT02847624). 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.