Phase 3
N=13
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
Autosomal Dominant Polycystic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01022424 ↗Enrolled (actual)
13
Serious AEs
46.2%
Results posted
Jul 2018
Primary outcome: Primary: Total Kidney Volume — 1428; 1675; 1728; 1775 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OPC-41061 (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Kidney Volume |
1428; 1675; 1728; 1775; 1901 | — |
| PRIMARY Renal Function Test (eGFR) |
63.0; 60.0; 54.0; 50.5; 51.0 | — |
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.
Eligibility Criteria
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- Patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the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
Data sourced from ClinicalTrials.gov (NCT01022424). 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.