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.
Study Type
OBSERVATIONAL
Enrollment
1,802
Otsuka Pharmaceutical Co., Ltd.
Tokyo, Japan
Estimated Slope of Total Kidney Volume During Pre-administration and Administration
Total Kidney Volume (TKV) was used as a biomarker to assess the progression of ADPKD. TKV was measured at each participating site based on imaging obtained via ultrasound, CT, or MRI. The Estimated Slope pre-administration was calculated for subjects who had TKV measurements both prior to and on the day of Tolvaptan initiation (baseline). The rate of change in TKV from the pre-treatment measurement date to the baseline was used to determine the Estimated Slope. Since the date of initiating tolvaptan administration is considered the start date of the study, the kidney volume measured prior to administration falls outside the study period (i.e., it is a value from before the study start date). The Estimated Slope during-treatment was calculated for subjects who had bilateral TKV measurements at baseline and during the treatment period. The rate of change in TKV from baseline to the measurement date during treatment was used to determine the Estimated Slope.
Time frame: Pre-administration: From the first pre-treatment measurement (up to 12.5 years prior) to the start of tolvaptan. During-treatment: From the start of tolvaptan to the final follow-up (up to 8.0 years later).
The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
Among cases included in the safety analysis, we counted and listed the number of patients whose ALT levels increased after starting tolvaptan but never exceeded three times the upper limit of normal (30 IU/L) at a specific time point (day) during treatment. Cases in which Tolvaptan treatment was discontinued were considered as dropouts on the day of discontinuation. The number of participants analyzed in each row of the data table is the same as the Overall Number of Participants Analyzed (n=1,672)
Time frame: From the date of Tolvaptan initiation to the earlier of either the date when ALT reached three times the upper limit of normal or the date of Tolvaptan discontinuation (up to 2789 days).
The Number of Cases in Which AST Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
Among cases included in the safety analysis, we counted and listed the number of patients whose AST levels increased after starting tolvaptan but never exceeded three times the upper limit of normal (30 IU/L) at a specific time point (day) during treatment. Cases in which Tolvaptan treatment was discontinued were considered as dropouts on the day of discontinuation. The number of participants analyzed in each row of the data table is the same as the Overall Number of Participants Analyzed (n=1,672)
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Time frame: From the date of Tolvaptan initiation to the earlier of either the date when AST reached three times the upper limit of normal or the date of Tolvaptan discontinuation (up to 2789 days).