Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-13 @ 8:05 PM
Study NCT ID:
NCT04408820
Status:
COMPLETED
Last Update Posted:
2025-07-25
First Post:
2020-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-marketing Surveillance of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia
Sponsor:
Astellas Pharma Inc
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: