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

Active, not recruiting

• Conditions: Renal Anemia
• Interventions: Drug: Roxadustat

• Registration Number: NCT04408820
• Lead Sponsor: Astellas Pharma Inc

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.

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 Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-29
• Study Start: 2020-06-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2104

Inclusion Criteria

• Renal anemia patients who are naïve to roxadustat.

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Roxadustat	Roxadustat	Participants will receive oral dose of roxadustat.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with hypertension	Up to Week 104	Number of participants with hypertension compared to number of participants evaluated.
Mean value of Hb levels over time	Up to Week 104	Hb will be measured throughout the period.
Proportion of participants with Adverse Drug Reactions (ADR)	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 malignant tumors	Up to Week 104	Number of participants with malignant tumors compared to number of participants evaluated.
Proportion of Participants With Serious Infection	Up to week 104	Number of participants with serious infection will be reported.
Proportion of participants with serious ADR	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	Up to Week 104	Number of participants with thromboembolism compared to number of participants evaluated.
Proportion of participants with retinal hemorrhage	Up to Week 104	Number of participants with retinal hemorrhage compared to number of participants evaluated.
Proportion of Participants With Central Hypothyroidsm	Up to Week 104	Number of participants with central hypothyroidsm compared to number of participants evaluated.
Proportion of Participants With Renal Function Disorder	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 with high doses of roxadustat	Up to Week 104	Number of participants with ADR with high doses of roxadustat compared to number of participants evaluated.
Proportion of Participants With Seizures	Up to week 104	Number of participants with seizures will be reported.
Proportion of participants with ADR within 4 weeks after switching to roxadustat	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 hepatic function disorder	Up to Week 104	Number of participants with hepatic function disorder compared to number of participants evaluated.
Proportion of participants with myopathy events	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.
Change from baseline in Hemoglobin (Hb) levels	Up to Week 104	Hb will be recorded from blood samples collected.
Achievement rate for target Hb level	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	At Week 4	Hb levels at 4 weeks after switching from ESA to roxadustat.

Trial Locations

Locations (47)

Site JP00023; 🇯🇵 Aichi, Japan

Site JP00005; 🇯🇵 Akita, Japan

Site JP00002; 🇯🇵 Aomori, Japan

Site JP00012; 🇯🇵 Chiba, Japan

Site JP00038; 🇯🇵 Ehime, Japan

Site JP00018; 🇯🇵 Fukui, Japan

Site JP00040; 🇯🇵 Fukuoka, Japan

Site JP00007; 🇯🇵 Fukushima, Japan

Site JP00021; 🇯🇵 Gifu, Japan

Site JP00010; 🇯🇵 Gunma, Japan

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