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

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.

Study Overview

• Status: Completed
• Conditions: Renal Anemia
• Intervention / Treatment: Drug: Roxadustat

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.

• Study Type: Observational
• Enrollment (Actual): 2104

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan
    • Site JP00023
  • Akita, Japan
    • Site JP00005
  • Aomori, Japan
    • Site JP00002
  • Chiba, Japan
    • Site JP00012
  • Ehime, Japan
    • Site JP00038
  • Fukui, Japan
    • Site JP00018
  • Fukuoka, Japan
    • Site JP00040
  • Fukushima, Japan
    • Site JP00007
  • Gifu, Japan
    • Site JP00021
  • Gunma, Japan
    • Site JP00010
  • Hiroshima, Japan
    • Site JP00034
  • Hokkaido, Japan
    • Site JP00001
  • Hyogo, Japan
    • Site JP00028
  • Ibaraki, Japan
    • Site JP00008
  • Ishikawa, Japan
    • Site JP00017
  • Iwate, Japan
    • Site JP00003
  • Kagawa, Japan
    • Site JP00037
  • Kagoshima, Japan
    • Site JP00046
  • Kanagawa, Japan
    • Site JP00014
  • Kochi, Japan
    • Site JP00039
  • Kumamoto, Japan
    • Site JP00043
  • Kyoto, Japan
    • Site JP00026
  • Mie, Japan
    • Site JP00024
  • Miyagi, Japan
    • Site JP00004
  • Miyazaki, Japan
    • Site JP00045
  • Nagano, Japan
    • Site JP00020
  • Nagasaki, Japan
    • Site JP00042
  • Nara, Japan
    • Site JP00029
  • Niigata, Japan
    • Site JP00015
  • Oita, Japan
    • Site JP00044
  • Okayama, Japan
    • Site JP00033
  • Okinawa, Japan
    • Site JP00047
  • Osaka, Japan
    • Site JP00027
  • Saga, Japan
    • Site JP00041
  • Saitama, Japan
    • Site JP00011
  • Shiga, Japan
    • Site JP00025
  • Shimane, Japan
    • Site JP00032
  • Shizuoka, Japan
    • Site JP00022
  • Tochigi, Japan
    • Site JP00009
  • Tokushima, Japan
    • Site JP00036
  • Tokyo, Japan
    • Site JP00013
  • Tottori, Japan
    • Site JP00031
  • Toyama, Japan
    • Site JP00016
  • Wakayama, Japan
    • Site JP00030
  • Yamagata, Japan
    • Site JP00006
  • Yamaguchi, Japan
    • Site JP00035
  • Yamanashi, Japan
    • Site JP00019

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Renal anemia patients on dialysis and non-dialysis who are naïve to roxadustat

Description

Inclusion Criteria:

• Renal anemia patients who are naïve to roxadustat.

Exclusion Criteria:

• Not applicable

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Roxadustat; Participants will receive oral dose of roxadustat.	Drug: Roxadustat; Oral; Other Names: ASP1517; Evrenzo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with Adverse Drug Reactions (ADR)	An AE is defined as any unwanted medical occurrence after drug administration and which does not necessarily have a causal relationship with the treatment. ADR is AEs whose relationship to the study drugs could not be ruled out is considered adverse drug reaction. AEs that fall under either "Probable" or "Possible" or "Unassessable" should be defined as "AEs whose relationship to the study drugs could not be ruled out.	Up to Week 104
Proportion of participants with serious ADR	ADR is considered "serious" if, in the view of the investigator, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.	Up to Week 104
Proportion of participants with thromboembolism	Number of participants with thromboembolism compared to number of participants evaluated.	Up to Week 104
Proportion of participants with hypertension	Number of participants with hypertension compared to number of participants evaluated.	Up to Week 104
Proportion of participants with hepatic function disorder	Number of participants with hepatic function disorder compared to number of participants evaluated.	Up to Week 104
Proportion of participants with malignant tumors	Number of participants with malignant tumors compared to number of participants evaluated.	Up to Week 104
Proportion of participants with retinal hemorrhage	Number of participants with retinal hemorrhage compared to number of participants evaluated.	Up to Week 104
Proportion of Participants With Seizures	Number of participants with seizures will be reported.	Up to week 104
Proportion of Participants With Serious Infection	Number of participants with serious infection will be reported.	Up to week 104
Proportion of participants with myopathy events	Number of participants with myopathy events related to the concomitant use of hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors compared to number of participants evaluated.	Up to Week 104
Proportion of Participants With Renal Function Disorder	Number of participants with renal function disorder reported as adverse drug reaction in participants with autosomal dominant polycystic kidney disease (ADPKD) will be reported.	Up to week 104
Proportion of participants with ADR within 4 weeks after switching to roxadustat	Number of participants with ADR within 4 weeks after switching from erythropoiesis stimulating agent (ESA) to roxadustat compared to number of participants evaluated.	Up to Week 4
Proportion of participants with ADR with high doses of roxadustat	Number of participants with ADR with high doses of roxadustat compared to number of participants evaluated.	Up to Week 104
Change from baseline in Hemoglobin (Hb) levels	Hb will be recorded from blood samples collected.	Up to Week 104
Mean value of Hb levels over time	Hb will be measured throughout the period.	Up to Week 104
Achievement rate for target Hb level	Percent of participants who achieved target Hb level (10.0 to 12.0 g/dL).	Up to Week 104
Mean Hb levels at 4 weeks after switching to roxadustat	Hb levels at 4 weeks after switching from ESA to roxadustat.	At Week 4
Proportion of Participants With Central Hypothyroidsm	Number of participants with central hypothyroidsm compared to number of participants evaluated.	Up to Week 104

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Study Director: Astellas Pharma Inc., Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): June 23, 2025
• Study Completion (Actual): June 23, 2025

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Roxadustat; ASP1517; Evrenzo
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: 1517-MA-3318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No