Clinical trial NCT04408820: Post-marketing Surveillance of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Anemia
Keywords: ASP1517
Evrenzo
Roxadustat
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2020-05-29
Enrollment: 2104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal anemia patients on dialysis and non-dialysis who are naïve to roxadustat

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.

Eligibility criteria: Inclusion Criteria:

* Renal anemia patients who are naïve to roxadustat.

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Proportion of participants with Adverse Drug Reactions (ADR)
timeFrame: Up to Week 104
measure: Proportion of participants with serious ADR
timeFrame: Up to Week 104
measure: Proportion of participants with thromboembolism
timeFrame: Up to Week 104
measure: Proportion of participants with hypertension
timeFrame: Up to Week 104
measure: Proportion of participants with hepatic function disorder
timeFrame: Up to Week 104
measure: Proportion of participants with malignant tumors
timeFrame: Up to Week 104
measure: Proportion of participants with retinal hemorrhage
timeFrame: Up to Week 104
measure: Proportion of Participants With Seizures
timeFrame: Up to week 104
measure: Proportion of Participants With Serious Infection
timeFrame: Up to week 104
measure: Proportion of Participants With Central Hypothyroidsm
timeFrame: Up to Week 104
measure: Proportion of participants with myopathy events
timeFrame: Up to Week 104
measure: Proportion of Participants With Renal Function Disorder
timeFrame: Up to week 104
measure: Proportion of participants with ADR within 4 weeks after switching to roxadustat
timeFrame: Up to Week 4
measure: Proportion of participants with ADR with high doses of roxadustat
timeFrame: Up to Week 104
measure: Change from baseline in Hemoglobin (Hb) levels
timeFrame: Up to Week 104
measure: Mean value of Hb levels over time
timeFrame: Up to Week 104
measure: Achievement rate for target Hb level
timeFrame: Up to Week 104
measure: Mean Hb levels at 4 weeks after switching to roxadustat
timeFrame: At Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site JP00023
city: Akita
country: Japan
facility: Site JP00005
city: Aomori
country: Japan
facility: Site JP00002
city: Chiba
country: Japan
facility: Site JP00012
city: Ehime
country: Japan
facility: Site JP00038
city: Fukui
country: Japan
facility: Site JP00018
city: Fukuoka
country: Japan
facility: Site JP00040
city: Fukushima
country: Japan
facility: Site JP00007
city: Gifu
country: Japan
facility: Site JP00021
city: Gunma
country: Japan
facility: Site JP00010
city: Hiroshima
country: Japan
facility: Site JP00034
city: Hokkaido
country: Japan
facility: Site JP00001
city: Hyogo
country: Japan
facility: Site JP00028
city: Ibaraki
country: Japan
facility: Site JP00008
city: Ishikawa
country: Japan
facility: Site JP00017
city: Iwate
country: Japan
facility: Site JP00003
city: Kagawa
country: Japan
facility: Site JP00037
city: Kagoshima
country: Japan
facility: Site JP00046
city: Kanagawa
country: Japan
facility: Site JP00014
city: Kochi
country: Japan
facility: Site JP00039
city: Kumamoto
country: Japan
facility: Site JP00043
city: Kyoto
country: Japan
facility: Site JP00026
city: Mie
country: Japan
facility: Site JP00024
city: Miyagi
country: Japan
facility: Site JP00004
city: Miyazaki
country: Japan
facility: Site JP00045
city: Nagano
country: Japan
facility: Site JP00020
city: Nagasaki
country: Japan
facility: Site JP00042
city: Nara
country: Japan
facility: Site JP00029
city: Niigata
country: Japan
facility: Site JP00015
city: Oita
country: Japan
facility: Site JP00044
city: Okayama
country: Japan
facility: Site JP00033
city: Okinawa
country: Japan
facility: Site JP00047
city: Osaka
country: Japan
facility: Site JP00027
city: Saga
country: Japan
facility: Site JP00041
city: Saitama
country: Japan
facility: Site JP00011
city: Shiga
country: Japan
facility: Site JP00025
city: Shimane
country: Japan
facility: Site JP00032
city: Shizuoka
country: Japan
facility: Site JP00022
city: Tochigi
country: Japan
facility: Site JP00009
city: Tokushima
country: Japan
facility: Site JP00036
city: Tokyo
country: Japan
facility: Site JP00013
city: Tottori
country: Japan
facility: Site JP00031
city: Toyama
country: Japan
facility: Site JP00016
city: Wakayama
country: Japan
facility: Site JP00030
city: Yamagata
country: Japan
facility: Site JP00006
city: Yamaguchi
country: Japan
facility: Site JP00035
city: Yamanashi
country: Japan
facility: Site JP00019
Study officials:
affiliation: Astellas Pharma Inc
name: Astellas Pharma Inc.
role: STUDY_DIRECTOR
References: