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NCT04408820 Clinical Trial

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

Renal Anemia Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04408820
Other study ID # 1517-MA-3318
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date March 31, 2025

Study information
Verified date May 2024
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2104
Est. completion date March 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Renal anemia patients who are naïve to roxadustat. Exclusion Criteria: - Not applicable

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Roxadustat
Oral
See more »

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Proportion of participants with thromboembolism Number of participants with thromboembolism compared to number of participants evaluated. Up to Week 104
Primary Proportion of participants with hypertension Number of participants with hypertension compared to number of participants evaluated. Up to Week 104
Primary Proportion of participants with hepatic function disorder Number of participants with hepatic function disorder compared to number of participants evaluated. Up to Week 104
Primary Proportion of participants with malignant tumors Number of participants with malignant tumors compared to number of participants evaluated. Up to Week 104
Primary Proportion of participants with retinal hemorrhage Number of participants with retinal hemorrhage compared to number of participants evaluated. Up to Week 104
Primary Proportion of Participants With Seizures Number of participants with seizures will be reported. Up to week 104
Primary Proportion of Participants With Serious Infection Number of participants with serious infection will be reported. Up to week 104
Primary Proportion of Participants With Central Hypothyroidsm Number of participants with central hypothyroidsm compared to number of participants evaluated. Up to Week 104
Primary 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
Primary 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
Primary 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
Primary 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
Primary Change from baseline in Hemoglobin (Hb) levels Hb will be recorded from blood samples collected. Up to Week 104
Primary Mean value of Hb levels over time Hb will be measured throughout the period. Up to Week 104
Primary 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
Primary Mean Hb levels at 4 weeks after switching to roxadustat Hb levels at 4 weeks after switching from ESA to roxadustat. At Week 4
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