Renal Anemia
Conditions
Keywords
ASP1517, Evrenzo, 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.
Interventions
DRUGRoxadustat
Oral
Sponsors
Astellas Pharma Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Renal anemia patients who are naïve to roxadustat.
Exclusion criteria
* Not applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 hypertension | Up to Week 104 | Number of participants with hypertension compared to number of participants evaluated. |
| 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 malignant tumors | Up to Week 104 | Number of participants with malignant tumors 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 Seizures | Up to week 104 | Number of participants with seizures will be reported. |
| Proportion of Participants With Serious Infection | Up to week 104 | Number of participants with serious infection will be reported. |
| 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 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. |
| 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 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. |
| 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. |
| Change from baseline in Hemoglobin (Hb) levels | Up to Week 104 | Hb will be recorded from blood samples collected. |
| Mean value of Hb levels over time | Up to Week 104 | Hb will be measured throughout the period. |
| 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. |
Countries
Japan
Outcome results
None listed