8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD) (NOCTURNE)

August 30, 2018 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Placebo-masked, Parallel-group Pilot Trial to Compare the Efficacy, Tolerability, and Safety of Tolvaptan Modified-release and Immediate-release Formulations in Subjects With Autosomal Dominant Polycystic Kidney Disease

The purpose of this study is to compare the short-term effects of two tolvaptan formulations in patients with ADPKD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
178

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35802
        • Otsuka Investigational Site
      • Mobile, Alabama, United States, 36617
        • Otsuka Investigational Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Otsuka Investigational Site
      • Tempe, Arizona, United States, 85284
        • Otsuka Investigational Site
    • California
      • Los Angeles, California, United States, 90025
        • Otsuka Investigational Site
      • San Diego, California, United States, 92108
        • Otsuka Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Otsuka Investigational Site 2
      • Aurora, Colorado, United States, 80045
        • Otsuka Investigational Site
      • Denver, Colorado, United States, 80210
        • Otsuka Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Otsuka Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Otsuka Investigational Site
      • Melbourne, Florida, United States, 32935
        • Otsuka Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Otsuka Investigational Site
      • Augusta, Georgia, United States, 30901
        • Otsuka Investigational Site
    • Illinois
      • Peoria, Illinois, United States, 61602
        • Otsuka Investigational Site
    • Indiana
      • Mishawaka, Indiana, United States, 46545
        • Otsuka Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Otsuka Investigational Site
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Otsuka Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Otsuka Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Otsuka Investigational Site
      • Rockville, Maryland, United States, 20850
        • Otsuka Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Otsuka Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Otsuka Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Otsuka Investigational Site
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Otsuka Investigational Site
    • New York
      • Buffalo, New York, United States, 14215
        • Otsuka Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Otsuka Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Otsuka Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Otsuka Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Otsuka Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Otsuka Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Otsuka Investigational Site
    • Texas
      • Arlington, Texas, United States, 76015
        • Otsuka Investigational Site
      • Mission, Texas, United States, 78572
        • Otsuka Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Otsuka Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 to 50

  2. Subjects with:

    • BMI between 19 and 35 kg/m2

    • diagnosis of ADPKD by modified Ravine criteria:

      • family history: 3cysts/kidney if by sonography or 5 by CT or MRI
      • Without family history: 10 cysts per kidney
    • an eGFR > 45 mL/min/1.73 m2 by the CKD-EPI equation
  3. Subjects not planning to become pregnant willing to comply with birth control requirements.
  4. Subjects must be in good health as determined by screening tests.
  5. Subjects providing informed consent and able to comply with all trial requirements.

Exclusion Criteria:

  1. Subjects using diuretics within 14 days prior to randomization, or the requirement for intermittent or constant diuretic use for any reason
  2. Subjects who had an eGFR < 45 mL/min/1.73 m2 calculated based on the most recent historical creatinine during the last 12 months

  3. Subjects with:

    • incontinence, overactive bladder, or urinary retention (eg, BPH), meaning subjects with symptoms of frequent nocturia, as determined by medical history or urinary urgency should be carefully evaluated to exclude non-ADPKD GU issues prior to entry.
    • liver disease, liver function abnormalities, or serology other than that expected for ADPKD with cystic liver disease at baseline
    • a history of renal surgery or cyst drainage within 6 months of randomization
    • blood pressure 150/95 mmHg or < 90/40 mmHg.
    • heart rate outside the range of 40 to 90 bpm.
    • advanced diabetes with a history of poor control, evidence of significant renal disease renal cancer, single kidney, or recent renal surgery
    • other significant medical history that may interfere with the study objectives
    • significant abnormalities in serum sodium concentration (< 135 or > 145 mEq/L)
    • a history of drug and/or alcohol abuse within 2 years prior to screening
    • clinically significant allergic reactions to tolvaptan or chemically related structures such as benzazepines (eg, benzazepril, conivaptan, fenoldopam mesylate, or mirtazapine)
  4. Subjects having taken an investigational drug within 30 days preceding randomization on Day 0
  5. Subjects taking medications or having concomitant illnesses likely to confound endpoint assessments, including taking approved (ie, marketed) therapies for the purpose of affecting PKD cysts such as tolvaptan, somatostatin agonists (ie, octreotide, sandostatin), Rapamune (sirolimus), anti-sense RNA therapies, other vasopressin antagonists (eg, OPC-31260 [mozavaptan] and Vaprisol® [conivaptan]) or agonists (eg, desmopressin), and cyst reduction surgery
  6. Subjects on antihypertensives that have not been on the same antihypertensive regimen for at least 30 days prior to the first dose of IMP
  7. Subjects having contraindications to, or interference with, MRI assessments
  8. Subjects with a history of serious mental disorders that, in the opinion of the investigator, would exclude the subject from participating in this trial
  9. Subjects with previous exposure to tolvaptan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tolvaptan MR 50 mg
Tolvaptan MR 50 mg capsule and 2 placebo IR tablets ( 8 AM) and 1 placebo IR tablet (4 PM) daily.
Drug: Tolvaptan MR
50/80 mg capsules
Other Names:
  • OPC-41061
Drug: Placebo
tablet
Experimental: Tolvaptan MR 80 mg
Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (8 AM) and 1 placebo IR tablet (4 PM) daily.
Drug: Tolvaptan MR
50/80 mg capsules
Other Names:
  • OPC-41061
Drug: Placebo
tablet
Experimental: Tolvaptan IR 60/30 mg
Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (8 AM) and 1 tolvaptan IR 30-mg tablet (4 PM) daily.
Drug: Placebo
tablet
Drug: Tolvaptan IR
60/30 mg capsules
Other Names:
  • OPC-41061
Placebo Comparator: Placebo
Placebo MR capsule and 2 placebo IR tablets (8 AM) and 1 placebo IR tablet (4 PM) daily.
Drug: Placebo
tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Total Kidney Volume (TKV) at Week 3
Time Frame: Baseline to Week 3
The primary endpoint was percent change from baseline in TKV at Week 3. Total kidney volume is an important measure of disease progression. A 3-week time point is adequate to assess acute effects on kidney cyst shrinkage.
Baseline to Week 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)
Time Frame: Baseline to Week 8
The ADPKD-UIS was a self-administered questionnaire designed to measure ADPKD-related urinary symptoms in participants with ADPKD. This instrument contained 11 items in 3 domains (Urinary Frequency, Urinary Urgency, and Nocturia). Each item was scored using a scale of 1 to 5 (a higher score indicated increased difficulty/extremely bothered). The maximum total score is 55; 1: not difficult/not bothered at all; 55: extremely difficult/extremely bothered.
Baseline to Week 8
Percent Change From Baseline in TKV at Week 8.
Time Frame: Baseline to Week 8
Total kidney volume is an important measure of disease progression. A 3-week time point is adequate to assess acute effects on kidney cyst shrinkage.
Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 156-09-290

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autosomal Dominant Polycystic Kidney Disease

Clinical Trials on Tolvaptan MR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings