Autosomal Dominant Polycystic Kidney Disease
Conditions
Keywords
ADPKD, Tolvaptan
Brief summary
Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).
Detailed description
Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).
Interventions
DRUGOPC-41061
orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
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 5-day repeated administrations and the follow-up observation in the preceding study (156-04-001) * Patients in whom the safety of repeated administration was confirmed based on the investigator's reports from the preceding study (156-04-001)
Exclusion criteria
* Patients with serum creatinine concentration of 2.5 mg/dL or higher at the screening examination * 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 thereto) * Inability to personally give consent due to a mental disease * Patients with SBP (in sitting position) \<90 mm Hg (at screening examination) * Patients with history of massive bleeding or bleeding tendency * Patients with a history of drug or alcohol abuse within 6 months prior to the screening examination * Pregnant women, lactating women, or women who may become or plan to become pregnant * Patients who received any investigational drug other than OPC-41061 within 30 days prior to commencement of administration of OPC-41061 * Any patient who, in the opinion of the principle investigator or attending investigators, should not participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Kidney Volume | Baseline, week 24, 52, 104, and 156 | 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. 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 24, 48, 104, and 156 | 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 Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Creatinine over the withdrawal criteria | 1 |
| Overall Study | Death | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | OPC-41061 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 41.8 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment Japan | 17 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 17 |
| other Total, other adverse events | 17 / 17 |
| serious Total, serious adverse events | 2 / 17 |
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 24, 48, 104, and 156
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Renal Function Test (eGFR) | 63.0 mL/min/1.73m2 |
| Week 24 | Renal Function Test (eGFR) | 64.0 mL/min/1.73m2 |
| Week 52 | Renal Function Test (eGFR) | 64.0 mL/min/1.73m2 |
| Week 104 | Renal Function Test (eGFR) | 58.5 mL/min/1.73m2 |
| Week 156 | Renal Function Test (eGFR) | 59.0 mL/min/1.73m2 |
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. 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 24, 52, 104, and 156
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Total Kidney Volume | 1500.5 mL |
| Week 24 | Total Kidney Volume | 1573.1 mL |
| Week 52 | Total Kidney Volume | 1567.9 mL |
| Week 104 | Total Kidney Volume | 1729.4 mL |
| Week 156 | Total Kidney Volume | 1647.7 mL |