Post-marketing Surveillance of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia
Active, not recruiting
- Conditions
- Renal Anemia
- Registration Number
- NCT04408820
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 2104
Inclusion Criteria
Inclusion Criteria:<br><br> - Renal anemia patients who are naïve to roxadustat.<br><br>Exclusion Criteria:<br><br> - Not applicable
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants with Adverse Drug Reactions (ADR);Proportion of participants with serious ADR;Proportion of participants with thromboembolism;Proportion of participants with hypertension;Proportion of participants with hepatic function disorder;Proportion of participants with malignant tumors;Proportion of participants with retinal hemorrhage;Proportion of Participants With Seizures;Proportion of Participants With Serious Infection;Proportion of Participants With Central Hypothyroidsm;Proportion of participants with myopathy events;Proportion of Participants With Renal Function Disorder;Proportion of participants with ADR within 4 weeks after switching to roxadustat;Proportion of participants with ADR with high doses of roxadustat;Change from baseline in Hemoglobin (Hb) levels;Mean value of Hb levels over time;Achievement rate for target Hb level;Mean Hb levels at 4 weeks after switching to roxadustat
- Secondary Outcome Measures
Name Time Method