Post-marketing Surveillance of EVRENZO Tablets (Roxadustat) in Dialysis-dependent Patients With Renal Anemia

  • STATUS
    Recruiting
  • participants needed
    1000
  • sponsor
    Astellas Pharma Inc
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Updated on 5 August 2020
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dialysis
anemia

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 100years or below
Treatment Roxadustat
Clinical Study IdentifierNCT04408820
SponsorAstellas Pharma Inc
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Renal anemia patients on dialysis who are nave to roxadustat

Exclusion Criteria

Not applicable
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If 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.

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Complete 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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