UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025158
Receipt number 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 2022/03/11 14:11:08

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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 Yukiko
Middle name
Last name Hagihara

Organization

Labcorp Development Japan K.K.

Division name

Clinical Development Services

Zip code

104-6108

Address

Harumi Toriton Square Office Tower Y 8F 1-8-11, Harumi, Chuo-ku, Tokyo 104-6108

TEL

03-6837-9500

Homepage URL


Email

Yukiko.Hagihara@labcorp.com


Sponsor or person

Institute

Reata Pharmaceuticals, Inc.

Institute

Department

Personal name



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

Published


Result

URL related to results and publications

https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-000196-24/results

Number of participants that the trial has enrolled

202

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

Main results already published

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

2022 Year 03 Month 11 Day



Link to view the page

Value
https://center6.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