Unique ID issued by UMIN | UMIN000039943 |
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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 |
An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease
A Trial of Bardoxolone Methyl in Patients with Chronic Kidney Disease - EAGLE
An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease
A Trial of Bardoxolone Methyl in Patients with Chronic Kidney Disease - EAGLE
Japan | North America | Australia |
Europe |
Chronic Kidney Disease
Alport Syndrome
Autosomal Dominant Polycystic Kidney
Nephrology |
Others
NO
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.
Safety
Others
Phase III
Long-term safety as measured by incidence of adverse events and serious adverse events during the study duration
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Bardoxolone methyl
Not applicable |
Not applicable |
Male and Female
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.
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.
1030
1st name | Seemi |
Middle name | |
Last name | Khan |
Reata Pharmaceuticals, Inc.
Clinical Program Operations
75063
2801 Gateway Drive, Suite 150 Irving, TX
+1-617-838-4773
Seemi.Khan@reatapharma.com
1st name | - |
Middle name | |
Last name | Clinical trial information contact |
Kyowa Kirin Co., Ltd.
R&D Planning Department, R&D Division
100-0004
1-9-2 Otemachi, Chiyoda-ku, Tokyo
03-5205-7200
clinical.info.jp@kyowakirin.com
Reata Pharmaceuticals, Inc.
None
Self funding
Kyowa Kirin Co., Ltd.
Japan Community Health care Organization Sendai Hospital
2-1-1, Murasakiyama, Izumi-ku, Sendai-shi, Miyagi, Japan
022-378-9111
keiko-yoshino@cmicgroup.com
YES
NCT03749447
ClinicalTrials.gov
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)
2020 | Year | 03 | Month | 25 | Day |
Unpublished
270
Terminated
2019 | Year | 01 | Month | 31 | Day |
2020 | Year | 02 | Month | 04 | Day |
2019 | Year | 03 | Month | 08 | Day |
2023 | Year | 07 | Month | 13 | Day |
2023 | Year | 08 | Month | 07 | Day |
2023 | Year | 10 | Month | 23 | Day |
Target sample size and Anticipated trial start date are global information. Japanese status is different from them.
2020 | Year | 03 | Month | 25 | Day |
2024 | Year | 02 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045541
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