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]

Study Overview
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Brief Summary
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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).

Official Title
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A Multicenter, Open-label Extension 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]

Conditions
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Autosomal Dominant Polycystic Kidney Disease （ADPKD)

Intervention / Treatment
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* Drug: tolvaptan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 53 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tolvaptan<br>Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg. | Drug: tolvaptan<br>* Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Kidney Volume | Measured values of total kidney volume (sum of the volume of the left and right kidneys) during trial period. Twice-daily repeated oral administration of tolvaptan at daily doses of 60 to 120 mg. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. | Baseline, Month12, Month24, and Month36 | 
| Renal Function Test (eGFR) | Estimated glomerular filtration rate calculated by Japanese equation for eGFR during trial period. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. | Baseline, Month12, Month24, and Month36 | 
| Renal Function Test (Cys-C) | Measured values of serum cystatin C concentration during trial period. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. | Baseline, Month 12, Month 24, and Month 36 |