UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039943
Receipt number R000045541
Scientific Title An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease
Date of disclosure of the study information 2020/03/25
Last modified on 2024/02/06 09:37:27

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Basic information

Public title

An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease

Acronym

A Trial of Bardoxolone Methyl in Patients with Chronic Kidney Disease - EAGLE

Scientific Title

An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease

Scientific Title:Acronym

A Trial of Bardoxolone Methyl in Patients with Chronic Kidney Disease - EAGLE

Region

Japan North America Australia
Europe


Condition

Condition

Chronic Kidney Disease
Alport Syndrome
Autosomal Dominant Polycystic Kidney

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To provide continuing open-label treatment with bardoxolone methyl as part of this extended access program while collecting ongoing safety and tolerability data of bardoxolone methyl.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Long-term safety as measured by incidence of adverse events and serious adverse events during the study duration

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Bardoxolone methyl

Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who are participating (or who have participated) in qualifying studies and who have not been required to discontinue study treatment for protocol or safety reasons and who have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl and who, according to the assessment of the investigator, have a potential positive benefit-risk assessment for participating in the trial.
2. Meets the following eligibility criteria based on assessments from the prior qualifying study (last on-treatment visit) or from a screening visit, if applicable.
a. Not expected to reach end stage kidney disease (ESKD) or nephrotic syndrome within 12 weeks of study enrollment, in the investigator's judgement; subjects with eGFR <20 mL/min/1.73 m2 should be discussed with the medical monitor before enrollment (e.g., such subjects with an average rate of eGFR decline >1.0 mL/min/1.73 m2 per month in the 3 months prior to eligibility assessment may not be eligible);
b. BNP < 200 pg/mL at the last on-treatment visit in the prior qualifying study or at a new screening visit, if applicable;
c. No occurrence of a cardiovascular serious adverse event in the prior qualifying study or in the interval between the end of the qualifying study and the screening visit, if applicable.
3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
4. Evidence of a personally signed and dated informed consent document (and assent form if necessary) indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures.

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;
2. Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl;
3. Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while screening, taking study drug and 30 days after last study drug dose;
4. Women who are pregnant or breastfeeding;
5. Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason;
6. Known hypersensitivity to any component of the study drug.

Target sample size

1030


Research contact person

Name of lead principal investigator

1st name Seemi
Middle name
Last name Khan

Organization

Reata Pharmaceuticals, Inc.

Division name

Clinical Program Operations

Zip code

75063

Address

2801 Gateway Drive, Suite 150 Irving, TX

TEL

+1-617-838-4773

Email

Seemi.Khan@reatapharma.com


Public contact

Name of contact person

1st name -
Middle name
Last name Clinical trial information contact

Organization

Kyowa Kirin Co., Ltd.

Division name

R&D Planning Department, R&D Division

Zip code

100-0004

Address

1-9-2 Otemachi, Chiyoda-ku, Tokyo

TEL

03-5205-7200

Homepage URL


Email

clinical.info.jp@kyowakirin.com


Sponsor or person

Institute

Reata Pharmaceuticals, Inc.

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kyowa Kirin Co., Ltd.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japan Community Health care Organization Sendai Hospital

Address

2-1-1, Murasakiyama, Izumi-ku, Sendai-shi, Miyagi, Japan

Tel

022-378-9111

Email

keiko-yoshino@cmicgroup.com


Secondary IDs

Secondary IDs

YES

Study ID_1

NCT03749447

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

日本赤十字社愛知医療センター名古屋第二病院(愛知県)
独立行政法人地域医療機能推進機構仙台病院(宮城県)
地方独立行政法人埼玉県立病院機構 埼玉県立小児医療センター(埼玉県)
東京都立小児総合医療センター(東京都)
聖マリアンナ医科大学病院(神奈川県)
国立大学法人神戸大学医学部附属病院(兵庫県)
佐賀大学医学部附属病院(佐賀県)
順天堂大学医学部付属病院順天堂医院(東京都)


Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 25 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

270

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

Terminated

Date of protocol fixation

2019 Year 01 Month 31 Day

Date of IRB

2020 Year 02 Month 04 Day

Anticipated trial start date

2019 Year 03 Month 08 Day

Last follow-up date

2023 Year 07 Month 13 Day

Date of closure to data entry

2023 Year 08 Month 07 Day

Date trial data considered complete


Date analysis concluded

2023 Year 10 Month 23 Day


Other

Other related information

Target sample size and Anticipated trial start date are global information. Japanese status is different from them.


Management information

Registered date

2020 Year 03 Month 25 Day

Last modified on

2024 Year 02 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045541


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name