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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025158
Receipt No. R000028933
Scientific Title A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
Date of disclosure of the study information 2016/12/07
Last modified on 2020/06/09

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Basic information
Public title A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
Acronym A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
Scientific Title A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
Scientific Title:Acronym A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
Region
Japan North America South America
Australia Europe

Condition
Condition Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
Classification by specialty
Cardiology Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of bardoxolone methyl relative to placebo.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Change from baseline in six-minute-walk distance (6MWD) relative to placebo at Week 24
Key secondary outcomes *Improvement by at least one WHO functional class
*Increase from baseline in 6MWD by at least 10%
*Decrease from baseline in creatine kinase (as a surrogate biomarker for muscle injury and
inflammation) by at least 10%


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Drug: Bardoxolone Methyl
Bardoxolone methyl dose escalated to a maximum of 10 mg. Dosing period is up to 6 months.
Interventions/Control_2 Drug: Placebo Oral Capsule
Capsule containing an inert placebo is administrated up to 6 months.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1 Adult male and female patients 18 to 75 years of age upon study consent;
2 BMI 18.5 kgm2
3 Symptomatic pulmonary hypertension WHONYHA FC class II and III
4 WHO Group I PAH associated with connective tissue disease
5 Had a diagnostic right heart catheterization performed and documented within 36months prior to Day 1 that confirmed a diagnosis of PAH according to all the following criteria:
a Mean pulmonary artery pressure 25 mm Hg (at rest)
b Pulmonary capillary wedge pressure (PCWP)15 mm Hg
c Pulmonary vascular resistance 240 dyn seccm5 or 3 mm Hg/liter (L)min
6 Has BNP level 400 pg/mL
7 Had an average 6MWD 150 meters on two consecutive tests performed on different days prior to randomization, with both tests measuring within 15% of one another;
8 Has been receiving no more than two approved disease-specific PAH therapies. PAH therapy must have been at a stable dose for at least 90 days prior to Day 1. No additions or changes should be made to PAH therapies and doses should remain stable for the duration of the study;
6 Has BNP level 400 pmL
7 Had an average 6MWD 150 meters on two consecutive tests performed on different days prior to randomization, with both tests measuring within 15% of one another;
8 Has been receiving no more than two approved disease-specific PAH therapies. PAH therapy must have been at a stable dose for at least 90 days prior to Day 1. No additions or changes should be made to PAH therapies and doses should remain stable for the duration of the study;

etc
Key exclusion criteria 1 Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication within 30 days prior to Day 1;
2 Initiation of an exercise program for cardio-pulmonary rehabilitation within 90 days prior to Day1or planned initiation during the study;
3 Stopped receiving any PAH chronic therapy within 60 days prior to Day 1;
4 Stopped receiving any PAH chronic therapy within 60 days prior to Day 1
Received a dose of prednisone 20 mg day (or equivalent dose if other corticosteroid) within 30 days prior to Day 1;

5 Received intravenous or subcutaneous prostacyclin/prostacyclin analogues within 90 days prior to Day 1;

6 Received intravenous inotropes within 30 days prior to Day 1;
7 Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) 160 mm Hg or sitting diastolic BP > 100 mm Hg during Screening after a period of rest
8 Has systolic BP 90 mm Hg during Screening after a period of rest
9 Has a history of clinically significant left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:
a Congenital or acquired valvular disease if clinically significant apart from tricuspid valvular insufficiency due to pulmonary hypertension;
b Pericardial constriction;
c Restrictive or congestive cardiomyopathy;
d Left ventricular ejection fraction 40% per echocardiogram (ECHO) within 90 days of Day 1;
e Symptomatic coronary artery disease within the last 3 years
10 Acutely decompensated heart failure within 30 days prior to Day 1, per investigator assessment
11 Has more than two of the following clinical risk factors for left ventricular diastolic dysfunction:
a Age 65 years;
b BMI 30 kgm2
c History of systemic hypertension;
d History of type 2 diabetes;
e History of atrial fibrillation

etc
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Colin
Middle name
Last name Meyer
Organization Reata Pharmaceuticals
Division name Product Development
Zip code TX 75063
Address 2801 Gateway Drive, Suite 150 Irving
TEL 1-972-865-2202
Email Colin.Meyer@reatapharma.com

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Kimura
Organization Covance Japan Co., Ltd.
Division name Clinical Development Services
Zip code 1046108
Address Harumi Toriton Square Office Tower Y 8F 1-8-11, Harumi, Chuo-ku, Tokyo 104-6108
TEL 03-6837-9500
Homepage URL
Email takahiro.kimura@covance.com

Sponsor
Institute Reata Pharmaceuticals, Inc.
Institute
Department

Funding Source
Organization Reata Pharmaceuticals, Inc.
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Unites States of America

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Okayama Medical Center Institutional Review Board
Address 1711-1 Tamasu, Kita-ku, Okayama-shi, Okayama
Tel 086-294-9911
Email chiken-crc@okayamamc.jp

Secondary IDs
Secondary IDs YES
Study ID_1 US IND NUMBER: 119,235
Org. issuing International ID_1 US IND
Study ID_2 EUDRACT NUMBER: 2016-000196-24
Org. issuing International ID_2 EUDRACT
IND to MHLW 22-1359

Institutions
Institutions 北海道大学病院(北海道)
東北大学病院(宮城県)
群馬大学医学部附属病院(群馬県)
千葉大学医学部附属病院(千葉県)
日本医科大学付属病院(東京都)
北里大学病院(神奈川県)
藤田医科大学病院(愛知県)
独立行政法人国立病院機構 名古屋医療センター(愛知県)
国立研究開発法人 国立循環器病研究センター病院(大阪府)
独立行政法人国立病院機構 岡山医療センター(岡山県)
神戸大学医学部付属病院(兵庫県)
久留米大学医学部附属病院(福岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 200
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 01 Month 27 Day
Date of IRB
2016 Year 07 Month 29 Day
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2020 Year 06 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 06 Day
Last modified on
2020 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028933

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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