NCT04408820

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

Specified Drug Use-Results Survey of EVRENZO® Tablets: Non-interventional, Prospective Drug Use-results Survey in the Realworld Use of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,104 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Renal Anemia

Interventions

Type	Name	Description
DRUG	Roxadustat	Oral

Timeline

• Start date: 2020-06-01
• Primary completion: 2025-06-23
• Completion: 2025-06-23
• First posted: 2020-05-29
• Last updated: 2025-07-25

Locations

47 sites across 1 country: Japan