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

Overview

The purpose of this study is to assess the safety and efficacy, including the incidence of thromboembolism, in renal anemia patients on dialysis treated with roxadustat (EVRENZO® Tablets) in actual clinical settings.

Full Title of Study: “Specified Drug Use-Results Survey of EVRENZO® Tablets: Non-interventional, Prospective Drug Use-results Survey in the Realworld Use of EVRENZO® Tablets (Roxadustat) in Dialysis-dependent Patients With Renal Anemia”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 31, 2025

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.

Interventions

  • Drug: Roxadustat
    • Oral

Arms, Groups and Cohorts

  • Roxadustat
    • Participants will receive oral dose of roxadustat.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • Proportion of participants with thromboembolism
    • Time Frame: Up to Week 104
    • Number of participants with thromboembolism compared to number of participants evaluated.
  • Proportion of participants with hypertension
    • Time Frame: Up to Week 104
    • Number of participants with hypertension compared to number of participants evaluated.
  • 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.
  • Proportion of participants with malignant tumors
    • Time Frame: Up to Week 104
    • Number of participants with malignant tumors compared to number of participants evaluated.
  • Proportion of participants with retinal hemorrhage
    • Time Frame: Up to Week 104
    • Number of participants with retinal hemorrhage compared to number of participants evaluated.
  • Proportion of Participants With Seizures
    • Time Frame: Up to week 104
    • Number of participants with seizures will be reported.
  • Proportion of Participants With Serious Infection
    • Time Frame: Up to week 104
    • Number of participants with serious infection will be reported.
  • 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.
  • 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.
  • 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.
  • 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.
  • Change from baseline in Hemoglobin (Hb) levels
    • Time Frame: Up to Week 104
    • Hb will be recorded from blood samples collected.
  • Mean value of Hb levels over time
    • Time Frame: Up to Week 104
    • Hb will be measured throughout the period.
  • 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).
  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Renal anemia patients on dialysis who are naïve to roxadustat Exclusion Criteria:

  • Not applicable

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Astellas Pharma Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Astellas Pharma Inc., Study Director, Astellas Pharma Inc
  • Overall Contact(s)
    • Astellas Pharma Inc., +81-3-3244-6500 Japanese only, Astellas.registration@astellas.com

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