drugset / Trial / NCT06466785
A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
RandomizedParallel-groupSingle-blindTreatment
Summary
An investigator-blinded, randomized, multicenter, active-controlled Phase III study for the treatment of anemia in patients with CKD on hemodialysis
Timeline
- Start
- 2024-01-25
- Primary completion
- 2027-06
- Completion
- 2028-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 20 ug | Intravenous |
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 30 ug | Intravenous |
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 60 ug | Intravenous |
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 100 ug | Intravenous |
| Subject | Efepoetin Alfa | Protein / enzyme biologic | 0.3 mg | Intravenous |
| Subject | Efepoetin Alfa | Protein / enzyme biologic | 0.6 mg | Intravenous |
| Subject | Efepoetin Alfa | Protein / enzyme biologic | 1 mg | Intravenous |