A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]

NCT00841568 | Completed Phase 2 Results

• 2 other identifiers: 156-05-002JapicCTI-090690
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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).

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

ADPKD; Tolvaptan

Outcome Measures

Primary Outcomes (2)

• 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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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.

  Baseline, week 24, 52, 104, and 156

• 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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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.

  Baseline, Week 24, 48, 104, and 156

Study Arms (1)

1

EXPERIMENTAL

Drug: OPC-41061

Interventions

OPC-41061 DRUG

orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kanto Region, Japan

Location

Related Publications (2)

• St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

  PMID: 39356039 DERIVED

• 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.

  PMID: 21903984 DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., Ltd.

+81-3-6361-7366

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 9, 2009
• First Posted: February 11, 2009
• Study Start: April 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 11, 2018
• Results First Posted: July 27, 2018

Record last verified: 2018-08

Locations

JP (1)