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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2025
  • participants needed
    2000
  • sponsor
    Astellas Pharma Inc
Updated on 16 July 2021
Investigator
Medical Affairs Europe
Primary Contact
Site JP00026 (1.4 mi away) Contact
+46 other location
dialysis

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, Renal Anaemia
Treatment Roxadustat
Clinical Study IdentifierNCT04408820
SponsorAstellas Pharma Inc
Last Modified on16 July 2021

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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