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Darbepoetin Alfa Monthly Dosing in ND-CKD Anemia
NCT07025460Phase 4
Key facts
- Status
- Active, not recruiting
- Start
- Dec 2019
- Primary completion
- Oct 2024
- Countries
- 1
- Sponsor
- Gangnam Severance Hospital
- Modality
- Erythropoietins, Colony Stimulating Factors
- Drugs
- darbepoetin alfa
- Conditions
- anemia
01
Overview
Phase 4, open-label, single-arm trial of darbepoetin alfa in anemia, sponsored by Gangnam Severance Hospital. Primary endpoint: Proportion of participants maintaining hemoglobin (Hb) ≥10.0 g/dL at Week 25. Started Dec 2019; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Once-monthly darbepoetin alfa group
Participants receive darbepoetin alfa administered subcutaneously once every 4 weeks.
03
Who it enrols
Adult patients with non-dialysis CKD (eGFR <= 45) and anemia, stable on biweekly darbepoetin alfa.
04
Endpoints
Primary
Proportion of participants maintaining hemoglobin (Hb) ≥10.0 g/dL
Secondary
Mean hemoglobin concentration
Response frequency
Proportion of patients with Hb <10 g/dL or >11 g/dL
Change in iron parameters (serum ferritin, transferrin saturation)
Total darbepoetin alfa dose administered
Requirement for oral iron supplementation
Incidence of adverse events
Blood pressure changes
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