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

NCT04408820 | Completed

• 1 other identifier: 1517-MA-3318
• Study Type: observational
• Target: 2,104
• Locations: 1 country
• Sites: 47

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.

Conditions

Renal Anemia

Keywords

ASP1517; Evrenzo; Roxadustat

Outcome Measures

Primary Outcomes (18)

• 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 Central Hypothyroidsm

  Number of participants with central hypothyroidsm compared to number of participants evaluated.

  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

Study Arms (1)

Roxadustat

Participants will receive oral dose of roxadustat.

Drug: Roxadustat

Interventions

Roxadustat DRUG

Oral

Also known as: ASP1517, Evrenzo

Roxadustat

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Renal anemia patients who are naïve to roxadustat.

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (47)

Site JP00023

Aichi, Japan

Location

Site JP00005

Akita, Japan

Location

Site JP00002

Aomori, Japan

Location

Site JP00012

Chiba, Japan

Location

Site JP00038

Ehime, Japan

Location

Site JP00018

Fukui, Japan

Location

Site JP00040

Fukuoka, Japan

Location

Site JP00007

Fukushima, Japan

Location

Site JP00021

Gifu, Japan

Location

Site JP00010

Gunma, Japan

Location

Site JP00034

Hiroshima, Japan

Location

Site JP00001

Hokkaido, Japan

Location

Site JP00028

Hyōgo, Japan

Location

Site JP00008

Ibaraki, Japan

Location

Site JP00017

Ishikawa, Japan

Location

Site JP00037

Kagawa, Japan

Location

Site JP00046

Kagoshima, Japan

Location

Site JP00014

Kanagawa, Japan

Location

Site JP00039

Kochi, Japan

Location

Site JP00043

Kumamoto, Japan

Location

Site JP00026

Kyoto, Japan

Location

Site JP00024

Mie, Japan

Location

Site JP00004

Miyagi, Japan

Location

Site JP00045

Miyazaki, Japan

Location

Site JP00020

Nagano, Japan

Location

Site JP00042

Nagasaki, Japan

Location

Site JP00029

Nara, Japan

Location

Site JP00015

Niigata, Japan

Location

Site JP00003

Numakunai, Japan

Location

Site JP00033

Okayama, Japan

Location

Site JP00047

Okinawa, Japan

Location

Site JP00027

Osaka, Japan

Location

Site JP00044

Ōita, Japan

Location

Site JP00041

Saga, Japan

Location

Site JP00011

Saitama, Japan

Location

Site JP00025

Shiga, Japan

Location

Site JP00032

Shimane, Japan

Location

Site JP00022

Shizuoka, Japan

Location

Site JP00009

Tochigi, Japan

Location

Site JP00036

Tokushima, Japan

Location

Site JP00013

Tokyo, Japan

Location

Site JP00031

Tottori, Japan

Location

Site JP00016

Toyama, Japan

Location

Site JP00030

Wakayama, Japan

Location

Site JP00006

Yamagata, Japan

Location

Site JP00035

Yamaguchi, Japan

Location

Site JP00019

Yamanashi, Japan

Location

Related Publications (1)

• Tsuruya K, Sugamori H, Tanaka Y, Wakasugi N, Ito Y. Real-world safety and effectiveness of roxadustat in patients with anemia of chronic kidney disease: interim results from a post-marketing surveillance study in Japan. Expert Opin Pharmacother. 2025 Mar;26(4):503-517. doi: 10.1080/14656566.2025.2462181. Epub 2025 Feb 7.

  PMID: 39899733 DERIVED

MeSH Terms

Interventions

roxadustat

Study Officials

• Astellas Pharma Inc.

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 29, 2020
• Study Start: June 1, 2020
• Primary Completion: June 23, 2025
• Study Completion: June 23, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (47)