Autosomal Dominant Polycystic Kidney Disease
Conditions
Keywords
ADPKD, Tolvaptan, OPC-41061
Brief summary
ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral administration of OPC-41061 at doses of 15 mg twice daily (morning and evening). Administration will be continued until the time of manufacturing and distribution approval of OPC-41061 for ADPKD in Japan.
Interventions
DRUGOPC-41061
Repeated oral administration at doses of 15 mg twice daily (morning and evening)
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the preceding study (156-05-002) * Patients in whom adverse events occurring in study 156-05-002 were resolved or became stable and do not require further follow-up.
Exclusion criteria
* Patients with eGFR of less than 15 mL/min/1.73 m2 * Patients with any of the following complications: * Uncontrolled hypertension * Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis) * Patients with any of the following complications or history thereof: * Clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity * Inability to personally give consent due to a mental illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Kidney Volume | Baseline, Week 48, 96, 144, and 192 | Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period. Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site. 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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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. |
| Renal Function Test (eGFR) | Baseline, Week 48, 96, 144, and 192 | Individual subject data on eGFR (estimated glomerular filtration rate calculated by Japanese eGFR equation) 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OPC-41061 Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.
Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | eGFR under the withdrawal criteria | 2 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | OPC-41061 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 45.6 years STANDARD_DEVIATION 9.2 |
| Region of Enrollment Japan | 13 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 13 / 13 |
| serious Total, serious adverse events | 6 / 13 |
Outcome results
Primary
Renal Function Test (eGFR)
Individual subject data on eGFR (estimated glomerular filtration rate calculated by Japanese eGFR equation) 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.
Time frame: Baseline, Week 48, 96, 144, and 192
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Renal Function Test (eGFR) | 63.0 mL/min/1.73 m2 |
| Week 48 | Renal Function Test (eGFR) | 60.0 mL/min/1.73 m2 |
| Week 96 | Renal Function Test (eGFR) | 54.0 mL/min/1.73 m2 |
| Week 144 | Renal Function Test (eGFR) | 50.5 mL/min/1.73 m2 |
| Week 192 | Renal Function Test (eGFR) | 51.0 mL/min/1.73 m2 |
Primary
Total Kidney Volume
Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period. Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site. 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.
Time frame: Baseline, Week 48, 96, 144, and 192
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Total Kidney Volume | 1428 mL |
| Week 48 | Total Kidney Volume | 1675 mL |
| Week 96 | Total Kidney Volume | 1728 mL |
| Week 144 | Total Kidney Volume | 1775 mL |
| Week 192 | Total Kidney Volume | 1901 mL |