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.
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 Type
OBSERVATIONAL
Enrollment
2,104
Oral
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.
Time frame: 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.
Time frame: Up to Week 104
Proportion of participants with thromboembolism
Number of participants with thromboembolism compared to number of participants evaluated.
Time frame: Up to Week 104
Proportion of participants with hypertension
Number of participants with hypertension compared to number of participants evaluated.
Time frame: Up to Week 104
Proportion of participants with hepatic function disorder
Number of participants with hepatic function disorder compared to number of participants evaluated.
Time frame: Up to Week 104
Proportion of participants with malignant tumors
Number of participants with malignant tumors compared to number of participants evaluated.
Time frame: Up to Week 104
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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
...and 37 more locations
Proportion of participants with retinal hemorrhage
Number of participants with retinal hemorrhage compared to number of participants evaluated.
Time frame: Up to Week 104
Proportion of Participants With Seizures
Number of participants with seizures will be reported.
Time frame: Up to week 104
Proportion of Participants With Serious Infection
Number of participants with serious infection will be reported.
Time frame: Up to week 104
Proportion of Participants With Central Hypothyroidsm
Number of participants with central hypothyroidsm compared to number of participants evaluated.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 104
Change from baseline in Hemoglobin (Hb) levels
Hb will be recorded from blood samples collected.
Time frame: Up to Week 104
Mean value of Hb levels over time
Hb will be measured throughout the period.
Time frame: 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).
Time frame: 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.
Time frame: At Week 4