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Authors
Ikejiri, Kazuaki https://orcid.org/0000-0001-6096-4723
Suzuki, Takafumi https://orcid.org/0000-0002-3425-8208
Muto, Satsuki https://orcid.org/0000-0002-9939-514X
Takama, Hirotaka https://orcid.org/0000-0003-1371-8540
Yamawaki, Kengo https://orcid.org/0000-0001-8962-1783
Miyazawa, Tatsuya https://orcid.org/0000-0002-9034-1508
Urakawa, Itaru https://orcid.org/0000-0003-3838-8461
Aoki, Yuichi https://orcid.org/0000-0003-3280-5076
Otsuki, Akihito https://orcid.org/0000-0003-1516-1010
Katsuoka, Fumiki https://orcid.org/0000-0003-0939-7887
Kinoshita, Kengo https://orcid.org/0000-0003-3453-2171
Nangaku, Masaomi https://orcid.org/0000-0001-7401-2934
Akizawa, Tadao https://orcid.org/0000-0002-6150-9201
Yamamoto, Masayuki https://orcid.org/0000-0002-9073-9436
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Clinical Trials BETA
Clinical trials referenced in this document:
nct02316821 at ClinicalTrials.govDocuments that mention this clinical trial
Effects of NRF2 polymorphisms on safety and efficacy of bardoxolone methyl: subanalysis of TSUBAKI study
https://doi.org/10.1007/s10157-023-02427-w
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Funding
Funding for this research was provided by:
Kyowa Kirin Co., Ltd.
The Tohoku Medical Megabank Project from the Ministry of Education, Culture, Sports, Science and Technology
The Japan Agency for Medical Research and Development (JP20km0105001, JP20km0105002)
Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (19H05649)
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Article History
Received: 18 March 2023
Accepted: 11 October 2023
First Online: 14 November 2023
Declarations
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: K. Ikejiri, S. Muto, H. Takama, K. Yamawaki, T. Miyazawa and I. Urakawa are employees of Kyowa Kirin. M. Nangaku has received research grants, consulting fees, and lecture fees from Kyowa Kirin and is vice president of the Japanese Society of Internal Medicine, president of the Asian Pacific Society of Nephrology, and president-elect of the International Society of Nephrology. T. Akizawa has received consulting fee and honoraria from Kyowa Kirin. T. Suzuki, Y. Aoki, A. Otsuki, F. Katsuoka, K. Kinoshita and M. Yamamoto declare no conflicts of interest.
: Approval for the study protocol and its amendments were obtained from the institutional review board at each study site and all work was carried out in accordance with the Declaration of Helsinki. The informed consent form (ICF) for the storage and use of blood samples for genome analysis was separate from the ICF for the TSUBAKI study participation. Whole blood samples for genome analysis were collected at baseline only from patients who provided written informed consent for both study participation and genome analysis. The genotyping substudy plan was established at the time of SNP analysis and approved by the ethics committee of Kyowa Kirin Co., Ltd. and ToMMo. Patients were also given the opportunity to exclude themselves from the substudy via an opt-out approach at study initiation.
