Post-marketing Surveillance of EVRENZO Tablets (Roxadustat) in Dialysis-dependent Patients With Renal Anemia
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- STATUS
- Recruiting
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- participants needed
- 1000
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- sponsor
- Astellas Pharma Inc
Summary
The purpose of this study is to assess the safety and efficacy, including the incidence of thromboembolism, in renal anemia patients on dialysis treated with roxadustat (EVRENZO Tablets) in actual clinical settings.
Description
This is a post-marketing long-term specified drug use-result survey study required for products in Japan. In the survey, patient registration and data collection will be conducted using post-marketing survey data collection system, PostMaNet via the Internet.
Patients who are eligible for the survey will be registered within 14 days after the start of treatment with roxadustat (including the start day of treatment). For all registered patients (including discontinuations/dropouts), the investigator will enter the necessary information in the case report form (CRF) and send it immediately after the end of the specified observation period for each patient.
Details
| Condition | renal anemia |
|---|---|
| Age | 100 years and younger |
| Treatment | Roxadustat |
| Clinical Study Identifier | NCT04408820 |
| Sponsor | Astellas Pharma Inc |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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