Skip to main content
OpenTrials
Completed

NCT Number: NCT04408820

Post-marketing Surveillance 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Anemia

Sex eligibility

All sexes

Study type

Observational

Primary location

Site JP00023, Aichi, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Renal anemia patients who are naïve to roxadustat.

Exclusion criteria

  • Not applicable

Treatment and study plan

Roxadustat

Drug

Oral

Other names: ASP1517, Evrenzo

Primary outcomes

  1. Proportion of participants with Adverse Drug Reactions (ADR)

    Time frame: Up to Week 104

    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.

  2. Proportion of participants with serious ADR

    Time frame: Up to Week 104

    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.

  3. Proportion of participants with thromboembolism

    Time frame: Up to Week 104

    Number of participants with thromboembolism compared to number of participants evaluated.

  4. Proportion of participants with hypertension

    Time frame: Up to Week 104

    Number of participants with hypertension compared to number of participants evaluated.

  5. Proportion of participants with hepatic function disorder

    Time frame: Up to Week 104

    Number of participants with hepatic function disorder compared to number of participants evaluated.

  6. Proportion of participants with malignant tumors

    Time frame: Up to Week 104

    Number of participants with malignant tumors compared to number of participants evaluated.

  7. Proportion of participants with retinal hemorrhage

    Time frame: Up to Week 104

    Number of participants with retinal hemorrhage compared to number of participants evaluated.

  8. Proportion of Participants With Seizures

    Time frame: Up to week 104

    Number of participants with seizures will be reported.

  9. Proportion of Participants With Serious Infection

    Time frame: Up to week 104

    Number of participants with serious infection will be reported.

  10. Proportion of Participants With Central Hypothyroidsm

    Time frame: Up to Week 104

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

  11. Proportion of participants with myopathy events

    Time frame: Up to Week 104

    Number of participants with myopathy events related to the concomitant use of hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors compared to number of participants evaluated.

  12. Proportion of Participants With Renal Function Disorder

    Time frame: Up to week 104

    Number of participants with renal function disorder reported as adverse drug reaction in participants with autosomal dominant polycystic kidney disease (ADPKD) will be reported.

  13. Proportion of participants with ADR within 4 weeks after switching to roxadustat

    Time frame: Up to Week 4

    Number of participants with ADR within 4 weeks after switching from erythropoiesis stimulating agent (ESA) to roxadustat compared to number of participants evaluated.

  14. Proportion of participants with ADR with high doses of roxadustat

    Time frame: Up to Week 104

    Number of participants with ADR with high doses of roxadustat compared to number of participants evaluated.

  15. Change from baseline in Hemoglobin (Hb) levels

    Time frame: Up to Week 104

    Hb will be recorded from blood samples collected.

  16. Mean value of Hb levels over time

    Time frame: Up to Week 104

    Hb will be measured throughout the period.

  17. Achievement rate for target Hb level

    Time frame: Up to Week 104

    Percent of participants who achieved target Hb level (10.0 to 12.0 g/dL).

  18. Mean Hb levels at 4 weeks after switching to roxadustat

    Time frame: At Week 4

    Hb levels at 4 weeks after switching from ESA to roxadustat.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 29, 2020
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.