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Trial record 15 of 95 for:    "Polycystic Kidney Disease"

Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier:
First received: September 25, 2014
Last updated: July 5, 2016
Last verified: July 2016
The purpose of the study is to evaluate and describe the long term safety of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD

Condition Intervention Phase
Autosomal Dominant Polycystic Kidney Disease
Drug: Tolvaptan (OPC-41061)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney Disease

Resource links provided by NLM:

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Safety variables [ Time Frame: From Baseline ] [ Designated as safety issue: Yes ]

    Clinically significant changes from baseline in abnormal clinical laboratory tests, vital signs and AEs will be summarized.The incidence of the following events will be summarized:

    1. Treatment-emergent AEs (TEAEs) by severity
    2. TEAEs potentially causally related to tolvaptan
    3. TEAEs with an outcome of death
    4. Serious TEAEs
    5. Discontinuations due to TEAEs

    Clinically significant serum transaminase elevations will be summarized by frequency (2x, 3x, 5x and 10x ULN), time to onset, time to peak levels, time to offset (< 3x, 2x, or 1x ULN)

    Frequency of progression to Hy's laboratory criteria (ALT or AST > 3x ULN and bilirubin, total (BT), > 2x ULN without alkaline phosphatase > 2x ULN)

    Serum sodium excursions above 145, 150, or 155 mmol/L or below 135, 130, or 125 mmol/L

Estimated Enrollment: 2500
Study Start Date: September 2014
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tolvaptan (OPC-41061) Drug: Tolvaptan (OPC-41061)
Tolvaptan tablets (15 or 30 mg) will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later

Detailed Description:
This trial is a phase 3b to evaluate and describe the long-term safety of tolvaptan treatment in ADPKD patients with CKD (chronic kidney disease). Eligible Subjects will enter the trial from Trial 156-08-271 or other Tolvaptan interventional trials. Renal function will be assessed during screening by using historical laboratory values for serum creatinine levels to calculate the estimated glomerular filtration rate (eGFR). General safety endpoints will be assessed and also relevant safety endpoints for the trial as Serum transaminase elevations in frequency & Serum sodium excursions.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male and female subjects ≥ 18 years with confirmed diagnosis of ADPKD (during participation in prior tolvaptan trials) who have

    • Completed and transferred from the double-blind Trial 156-13-210 (12-month period including post treatment follow-up, regardless of whether this was on-treatment or off-treatment), or
    • Completed Trial 156-08-271 or a prior tolvaptan trial, or
    • Interrupted or discontinued treatment in a prior tolvaptan ADPKD trial other than Trial 156-13-210. Subjects may be enrolled with the medical monitor approval, and additional close monitoring may be required at the beginning of the study
  2. Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73m2 within 45 days of the baseline visit. Subjects who have an eGFR between 15 and 19 mL/min/1.73m2 may be enrolled with medical monitor approval
  3. Diagnosis of ADPKD by modified Pei-Ravine criteria

Exclusion Criteria:

  • Need for chronic diuretic use
  • Hepatic impairment based on liver function assessments other than that expected for ADPKD with cystic liver disease
  • Women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP
  • Women who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP.
  • Subjects with contraindications to required trial assessments (contraindications to optional assessments, eg, MRI are not a limitation).
  • Subjects who in the opinion of the Investigator or the Medical Monitor, have a medical history or medical finding inconsistent with safety or trial compliance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02251275

  Show 126 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier: NCT02251275     History of Changes
Other Study ID Numbers: 156-13-211 
Study First Received: September 25, 2014
Last Updated: July 5, 2016
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Committee of Ethics in Research
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway:National Committee for Medical and Health Research Ethics
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Authority for Scientific Research
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Chile: Instituto de Salud Pública de Chile
Mexico: Federal Commission for Sanitary Risks Protection
Peru: Instituto Nacional de Salud
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
South Africa: Medicines Control Council
Denmark: Danish Health and Medicines Authority
Israel: Ministry of Health
New Zealand: Ministry of Health

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Autosomal Dominant Polycystic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs processed this record on October 21, 2016