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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Renal Anemia

Intervention / Treatment
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* Drug: Roxadustat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Renal anemia patients who are naïve to roxadustat. Exclusion Criteria: Not applicable
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Roxadustat<br>Participants will receive oral dose of roxadustat. | Drug: Roxadustat<br>* Oral<br>* Other names: Evrenzo;|

What is the study measuring?
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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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASP1517, Evrenzo, Roxadustat