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

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ClinicalTrials.gov Identifier: NCT02251275
Recruitment Status : Completed
First Posted : September 29, 2014
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Autosomal Dominant Polycystic Kidney Disease Drug: Tolvaptan (OPC-41061) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1814 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2014
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : November 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Tolvaptan

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Safety variables [ Time Frame: From Baseline ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251275


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Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02251275     History of Changes
Other Study ID Numbers: 156-13-211
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Autosomal Dominant Polycystic Kidney Disease
Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs