Post-marketing Surveillance of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2104
- Renal anemia patients who are naïve to roxadustat.
- 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 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 hypertension Up to Week 104 Number of participants with hypertension 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.
Mean value of Hb levels over time Up to Week 104 Hb will be measured throughout the period.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
Site JP00023
🇯🇵Aichi, Japan
Site JP00018
🇯🇵Fukui, Japan
Site JP00021
🇯🇵Gifu, Japan
Site JP00010
🇯🇵Gunma, Japan
Site JP00034
🇯🇵Hiroshima, Japan
Site JP00037
🇯🇵Kagawa, Japan
Site JP00046
🇯🇵Kagoshima, Japan
Site JP00033
🇯🇵Okayama, Japan
Site JP00011
🇯🇵Saitama, Japan
Site JP00041
🇯🇵Saga, Japan
Site JP00032
🇯🇵Shimane, Japan
Site JP00006
🇯🇵Yamagata, Japan
Site JP00019
🇯🇵Yamanashi, Japan
Site JP00035
🇯🇵Yamaguchi, Japan
Site JP00026
🇯🇵Kyoto, Japan
Site JP00029
🇯🇵Nara, Japan
Site JP00042
🇯🇵Nagasaki, Japan
Site JP00025
🇯🇵Shiga, Japan
Site JP00022
🇯🇵Shizuoka, Japan
Site JP00045
🇯🇵Miyazaki, Japan
Site JP00016
🇯🇵Toyama, Japan
Site JP00038
🇯🇵Ehime, Japan
Site JP00040
🇯🇵Fukuoka, Japan
Site JP00014
🇯🇵Kanagawa, Japan
Site JP00015
🇯🇵Niigata, Japan
Site JP00044
🇯🇵Oita, Japan
Site JP00047
🇯🇵Okinawa, Japan
Site JP00030
🇯🇵Wakayama, Japan
Site JP00005
🇯🇵Akita, Japan
Site JP00002
🇯🇵Aomori, Japan
Site JP00008
🇯🇵Ibaraki, Japan
Site JP00043
🇯🇵Kumamoto, Japan
Site JP00036
🇯🇵Tokushima, Japan
Site JP00013
🇯🇵Tokyo, Japan
Site JP00031
🇯🇵Tottori, Japan
Site JP00039
🇯🇵Kochi, Japan
Site JP00007
🇯🇵Fukushima, Japan
Site JP00001
🇯🇵Hokkaido, Japan
Site JP00028
🇯🇵Hyogo, Japan
Site JP00017
🇯🇵Ishikawa, Japan
Site JP00024
🇯🇵Mie, Japan
Site JP00004
🇯🇵Miyagi, Japan
Site JP00020
🇯🇵Nagano, Japan
Site JP00027
🇯🇵Osaka, Japan
Site JP00009
🇯🇵Tochigi, Japan
Site JP00012
🇯🇵Chiba, Japan
Site JP00003
🇯🇵Iwate, Japan