A Phase III, Randomized, Investigator-Blinded, Active-Controlled Study of Efficacy and Safety of Efepoetin Alfa for Treatment of Anemia in Patients with Chronic Kidney Disease on Dialysis

Conditions

Anemia in patients with chronic kidney disease on dialysis

Brief summary

The mean change from Baseline in Hb averaged over Week 20 to Week 28 without the use of rescue therapy* (i.e., transfusion, or any approved ESA) within 6 weeks prior to and during the 8-week evaluation period. Baseline value is defined as the mean of the last screening value and Day1 (Visit 2) value.

Detailed description

Mean change from Baseline in Hb averaged over Week 20 to Week 28, regardless of whether the patient received rescue therapy., Mean change from Baseline in Hb level averaged over the maintenance period, regardless of whether the patient received rescue therapy, Proportion of patients who maintain Hb level at 10.0-12.0 g/dL over Week 20 to Week 28*, and over the maintenance period, regardless of whether the patient received rescue therapy., Proportion of patients with mean Hb ≥ 10.0 g/dL averaged over Week 20 to Week 28*, and over the maintenance period, regardless of whether the patient received rescue therapy., Proportion of patients requiring rescue therapy during study treatment and time to rescue therapy from date of first dose of study treatment., Proportion of patients receiving rescue therapy over Week 20 to Week 28, and over the maintenance period., Mean dose of the IP over Week 20 to Week 28, and over the maintenance period., Mean change in QoL from Day 1 (V2) over time assessed through the 36-Item Health Survey 1.0 Questionnaire (Rand SF-36).

Related papers

No related papers found yet.

Interventions

DRUGGX-E4

DRUGAranesp 30 micrograms solution for injection in pre-filled syringe

DRUGAranesp 60 micrograms solution for injection in pre-filled syringe

DRUGAranesp 20 micrograms solution for injection in pre-filled syringe

DRUGAranesp 100 micrograms solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The mean change from Baseline in Hb averaged over Week 20 to Week 28 without the use of rescue therapy* (i.e., transfusion, or any approved ESA) within 6 weeks prior to and during the 8-week evaluation period. Baseline value is defined as the mean of the last screening value and Day1 (Visit 2) value.	—

Secondary

Measure	Time frame
Mean change from Baseline in Hb averaged over Week 20 to Week 28, regardless of whether the patient received rescue therapy., Mean change from Baseline in Hb level averaged over the maintenance period, regardless of whether the patient received rescue therapy, Proportion of patients who maintain Hb level at 10.0-12.0 g/dL over Week 20 to Week 28, and over the maintenance period, regardless of whether the patient received rescue therapy., Proportion of patients with mean Hb ≥ 10.0 g/dL averaged over Week 20 to Week 28, and over the maintenance period, regardless of whether the patient received rescue therapy., Proportion of patients requiring rescue therapy during study treatment and time to rescue therapy from date of first dose of study treatment., Proportion of patients receiving rescue therapy over Week 20 to Week 28, and over the maintenance period., Mean dose of the IP over Week 20 to Week 28, and over the maintenance period., Mean change in QoL from Day 1 (V2) over time assesse	—

Measure

Time frame

Mean change from Baseline in Hb averaged over Week 20 to Week 28, regardless of whether the patient received rescue therapy., Mean change from Baseline in Hb level averaged over the maintenance period, regardless of whether the patient received rescue therapy, Proportion of patients who maintain Hb level at 10.0-12.0 g/dL over Week 20 to Week 28*, and over the maintenance period, regardless of whether the patient received rescue therapy., Proportion of patients with mean Hb ≥ 10.0 g/dL averaged over Week 20 to Week 28*, and over the maintenance period, regardless of whether the patient received rescue therapy., Proportion of patients requiring rescue therapy during study treatment and time to rescue therapy from date of first dose of study treatment., Proportion of patients receiving rescue therapy over Week 20 to Week 28, and over the maintenance period., Mean dose of the IP over Week 20 to Week 28, and over the maintenance period., Mean change in QoL from Day 1 (V2) over time assesse

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Countries

Bulgaria, Czechia, Hungary, Italy, Poland

Outcome results

None listed