Peritoneal dialysis patients with renal anemia
Conditions
Interventions
Sponsors
Nippon Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. peritoneal dialysis patients with renal anemia who are receiving darbepoetin alpha 2. male and female, 20 years of age or older at the time of consent 3. patients on peritoneal dialysis for more than 8 weeks at the time of consent 4. patients receiving darbepoetin alpha for more than 16 weeks at the time of obtaining consent 5. Patients who have given their written consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. patients with a history of hypersensitivity to any component of daprodustat 2. patients with unstable or acute heart failure 3. patients with a history of thrombosis within 6 months 4. patients with severe hypertension (systolic blood pressure of 190 mmHg or higher or diastolic blood pressure of 120 mmHg or higher) 5. patients with malignant tumors 6. Patients with severe hepatic dysfunction (Child-Pugh C) 7. Patients receiving the following drugs: clopidocrel, trimethoprem, rifampicin 8. Patients who are pregnant, lactating, may be pregnant, or plan to become pregnant. 9. patients with proliferative diabetic retinopathy, macular edema, exudative age-related macular degeneration, retinal vein occlusion, etc. 10. patients who require a substitute. 11. Other patients deemed inappropriate by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean hemoglobin level from baseline to the primary efficacy evaluation period (defined as 20 to 24 weeks of treatment). The target hemoglobin level is defined as between 11.0 g/dL and 13.0 g/dL. | — |
Countries
Japan
Contacts
Public ContactTomohiro Yan
Nippon Medical School Department of Nephrology
Outcome results
None listed