Renal AnemiaNCT04408820
Post-marketing Surveillance of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia
An observational study of Renal Anemia, run by Astellas Pharma Inc at 47 sites in Japan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Anemia
- What is being tested?
- Roxadustat
- Type of treatment
- Pill or oral medicine
- How many people
- 2,104 participants
- Where
- 47 sitesJapan
- Study dates
- 1 Jun 2020to 23 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Renal anemia patients on dialysis and non-dialysis who are naïve to roxadustat
Who may be able to join
- Renal anemia patients who are naïve to roxadustat.
Who cannot join
- Not applicable
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Japan47 sites
Site JP00023
Aichi
Site JP00005
Akita
Site JP00002
Aomori
Site JP00012
Chiba
Site JP00038
Ehime
Site JP00018
Fukui
Site JP00040
Fukuoka
Site JP00007
Fukushima
Site JP00021
Gifu
Site JP00010
Gunma
Site JP00034
Hiroshima
Site JP00001
Hokkaido
Site JP00028
Hyōgo
Site JP00008
Ibaraki
Site JP00017
Ishikawa
Site JP00037
Kagawa
Site JP00046
Kagoshima
Site JP00014
Kanagawa
Site JP00039
Kochi
Site JP00043
Kumamoto
Site JP00026
Kyoto
Site JP00024
Mie
Site JP00004
Miyagi
Site JP00045
Miyazaki
Site JP00020
Nagano
Site JP00042
Nagasaki
Site JP00029
Nara
Site JP00015
Niigata
Site JP00003
Numakunai
Site JP00044
Ōita
Site JP00033
Okayama
Site JP00047
Okinawa
Site JP00027
Osaka
Site JP00041
Saga
Site JP00011
Saitama
Site JP00025
Shiga
Site JP00032
Shimane
Site JP00022
Shizuoka
Site JP00009
Tochigi
Site JP00036
Tokushima
Site JP00013
Tokyo
Site JP00031
Tottori
Site JP00016
Toyama
Site JP00030
Wakayama
Site JP00006
Yamagata
Site JP00035
Yamaguchi
Site JP00019
Yamanashi
About this study
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
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.
Read the 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.
- Conditions
- Renal Anemia
- Being tested
- Roxadustat
- Keywords
- ASP1517, Evrenzo, Roxadustat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
Also called ASP1517, Evrenzo
Oral
| Study group | Role | What they receive |
|---|---|---|
| Roxadustat | Participants will receive oral dose of roxadustat. Receives: Drug: Roxadustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to Week 104
Proportion of participants with thromboembolism
Number of participants with thromboembolism compared to number of participants evaluated.
Measured: Up to Week 104
Proportion of participants with hypertension
Number of participants with hypertension compared to number of participants evaluated.
Measured: Up to Week 104
Proportion of participants with hepatic function disorder
Number of participants with hepatic function disorder compared to number of participants evaluated.
Measured: Up to Week 104
Proportion of participants with malignant tumors
Number of participants with malignant tumors compared to number of participants evaluated.
Measured: Up to Week 104
Proportion of participants with retinal hemorrhage
Number of participants with retinal hemorrhage compared to number of participants evaluated.
Measured: Up to Week 104
Proportion of Participants With Seizures
Number of participants with seizures will be reported.
Measured: Up to week 104
Proportion of Participants With Serious Infection
Number of participants with serious infection will be reported.
Measured: Up to week 104
Proportion of Participants With Central Hypothyroidsm
Number of participants with central hypothyroidsm compared to number of participants evaluated.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 104
Change from baseline in Hemoglobin (Hb) levels
Hb will be recorded from blood samples collected.
Measured: Up to Week 104
Mean value of Hb levels over time
Hb will be measured throughout the period.
Measured: 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).
Measured: 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.
Measured: At Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Jun 2020
- Primary completion23 Jun 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Astellas Pharma Inc., Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408820
- Sponsor's protocol ID
- 1517-MA-3318
- Status last verified
- Jul 2025
- First submitted
- 26 May 2020
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/
Publications
Tsuruya K, Sugamori H, Tanaka Y, Wakasugi N, Ito Y. Real-world safety and effectiveness of roxadustat in patients with anemia of chronic kidney disease: interim results from a post-marketing surveillance study in Japan. Expert Opin Pharmacother. 2025 Mar;26(4):503-517. doi: 10.1080/14656566.2025.2462181. Epub 2025 Feb 7.
PubMed 39899733
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04408820
- Acronym / sponsor ID
- 1517-MA-3318
- Conditions
- Renal Anemia
- Keywords
- ASP1517, Evrenzo, Roxadustat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,104 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Roxadustat | – | Drug: RoxadustatParticipants will receive oral dose of roxadustat. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Renal anemia patients on dialysis and non-dialysis who are naïve to roxadustat
Key inclusion criteria (1 listed)
- Renal anemia patients who are naïve to roxadustat.
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoxadustatAlso: ASP1517, EvrenzoOral | Drug | Roxadustat |
Primary outcome
Proportion of participants with Adverse Drug Reactions (ADR)
Time frame: 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 serious ADR
Time frame: 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
Time frame: Up to Week 104
Number of participants with thromboembolism compared to number of participants evaluated.
Proportion of participants with hypertension
Time frame: Up to Week 104
Number of participants with hypertension compared to number of participants evaluated.
Proportion of participants with hepatic function disorder
Time frame: Up to Week 104
Number of participants with hepatic function disorder compared to number of participants evaluated.
Proportion of participants with malignant tumors
Time frame: Up to Week 104
Number of participants with malignant tumors compared to number of participants evaluated.
Proportion of participants with retinal hemorrhage
Time frame: Up to Week 104
Number of participants with retinal hemorrhage compared to number of participants evaluated.
Proportion of Participants With Seizures
Time frame: Up to week 104
Number of participants with seizures will be reported.
Proportion of Participants With Serious Infection
Time frame: Up to week 104
Number of participants with serious infection will be reported.
Proportion of Participants With Central Hypothyroidsm
Time frame: Up to Week 104
Number of participants with central hypothyroidsm compared to number of participants evaluated.
Proportion of participants with myopathy events
Time frame: 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.
Proportion of Participants With Renal Function Disorder
Time frame: 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 within 4 weeks after switching to roxadustat
Time frame: 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.
Proportion of participants with ADR with high doses of roxadustat
Time frame: Up to Week 104
Number of participants with ADR with high doses of roxadustat compared to number of participants evaluated.
Change from baseline in Hemoglobin (Hb) levels
Time frame: Up to Week 104
Hb will be recorded from blood samples collected.
Mean value of Hb levels over time
Time frame: Up to Week 104
Hb will be measured throughout the period.
Achievement rate for target Hb level
Time frame: 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
Time frame: At Week 4
Hb levels at 4 weeks after switching from ESA to roxadustat.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Derived from this study: PubMed 39899733Tsuruya K, Sugamori H, Tanaka Y, Wakasugi N, Ito Y. Real-world safety and effectiveness of roxadustat in patients with anemia of chronic kidney disease: interim results from a post-marketing surveillance study in Japan. Expert Opin Pharmacother. 2025 Mar;26(4):503-517. doi: 10.1080/14656566.2025.2462181. Epub 2025 Feb 7.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/
Related trials for Renal Anemia
Active, not recruitingObservational study
A Study to Learn More About the Long-term Safety and Effectiveness of Molidustat as a Treatment for Japanese Men and Women With Renal Anemia
Renal Anemia
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Active, not recruitingPhase 3
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Not yet recruitingPhase 1
Study of CTX001 in Adults With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease
Chronic Kidney Disease, Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astellas Pharma Inc. study director
Astellas Pharma Inc
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Anemia, run by Astellas Pharma Inc at 47 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with Adverse Drug Reactions (ADR) (time frame: Up to Week 104). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04408820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.