Clinical trial NCT00841568: A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
Official title: A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: ADPKD
Tolvaptan
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-02-11
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Total Kidney Volume
timeFrame: Baseline, week 24, 52, 104, and 156
measure: Renal Function Test (eGFR)
timeFrame: Baseline, Week 24, 48, 104, and 156
Secondary outcomes:
Other outcomes:
Locations:
city: Kanto Region
country: Japan
Study officials:
References:
citation: Higashihara E, Torres VE, Chapman AB, Grantham JJ, Bae K, Watnick TJ, Horie S, Nutahara K, Ouyang J, Krasa HB, Czerwiec FS; TEMPOFormula and 156-05-002 Study Investigators. Tolvaptan in autosomal dominant polycystic kidney disease: three years' experience. Clin J Am Soc Nephrol. 2011 Oct;6(10):2499-507. doi: 10.2215/CJN.03530411. Epub 2011 Sep 8.