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

Astellas

Status: Active, not recruiting

Conditions: Renal Anemia

Treatments: Drug: Roxadustat

Study type: Observational

Funder types: Industry

Identifiers

NCT04408820

1517-MA-3318

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy, including the incidence of thromboembolism, in renal anemia patients treated with roxadustat (EVRENZO® Tablets) in actual clinical settings.

Full 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.

Enrollment: 2,104 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Renal anemia patients who are naïve to roxadustat.

Exclusion criteria

• Not applicable

Trial design

2,104 participants in 1 patient group

Roxadustat

Description:

Participants will receive oral dose of roxadustat.

Treatment:

Drug: Roxadustat