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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Anemia
• Renal Anemia

Intervention

Drug:
• Roxadustat
Oral

Locations

Country	Name	City	State
Japan	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	Site JP00034	Hiroshima
Japan	Site JP00001	Hokkaido
Japan	Site JP00028	Hyogo
Japan	Site JP00008	Ibaraki
Japan	Site JP00017	Ishikawa
Japan	Site JP00003	Iwate
Japan	Site JP00037	Kagawa
Japan	Site JP00046	Kagoshima
Japan	Site JP00014	Kanagawa
Japan	Site JP00039	Kochi
Japan	Site JP00043	Kumamoto
Japan	Site JP00026	Kyoto
Japan	Site JP00024	Mie
Japan	Site JP00004	Miyagi
Japan	Site JP00045	Miyazaki
Japan	Site JP00020	Nagano
Japan	Site JP00042	Nagasaki
Japan	Site JP00029	Nara
Japan	Site JP00015	Niigata
Japan	Site JP00044	Oita
Japan	Site JP00033	Okayama
Japan	Site JP00047	Okinawa
Japan	Site JP00027	Osaka
Japan	Site JP00041	Saga
Japan	Site JP00011	Saitama
Japan	Site JP00025	Shiga
Japan	Site JP00032	Shimane
Japan	Site JP00022	Shizuoka
Japan	Site JP00009	Tochigi
Japan	Site JP00036	Tokushima
Japan	Site JP00013	Tokyo
Japan	Site JP00031	Tottori
Japan	Site JP00016	Toyama
Japan	Site JP00030	Wakayama
Japan	Site JP00006	Yamagata
Japan	Site JP00035	Yamaguchi
Japan	Site JP00019	Yamanashi

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