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Roxadustat for Anemia in Non-dialysis CKD Patients (ALPS)
NCT01887600Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2013
- Primary completion
- Nov 2017
- Countries
- 22
- Sponsor
- Astellas Pharma
- Modality
- Small Molecules
- Drugs
- roxadustat
- Conditions
- anemia
01
Overview
Phase 3, randomised, double-blind trial in anemia comparing Roxadustat Arm with Placebo Arm (2 arms). Primary endpoints: Percentage of Participants With a Hemoglobin Response to Treatment at 24 weeks and Hemoglobin Change From Baseline to Weeks 28-52. Started Sep 2013; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Roxadustat Arm
Oral roxadustat TIW, weight-based starting dose (70/100 mg).
Placebo Arm
Matching oral placebo TIW.
03
Who it enrols
Patients with Stage 3-5 CKD not on dialysis, with Hb <= 10.0 g/dL, ferritin >= 30 ng/mL, and TSAT >= 5%, excluding those with recent ESA or IV iron use.
04
Endpoints
Primary
Percentage of Participants With a Hemoglobin Response to Treatment
Hemoglobin Change From Baseline to Weeks 28-52
Secondary
Hemoglobin Change From Baseline to Weeks 28-36 Without Rescue Therapy
Change From Baseline in Low-Density Lipoprotein Cholesterol
Time to First Use of Rescue Therapy
Change From Baseline in SF-36 Vitality Sub-score
Change From Baseline in SF-36 Physical Functioning Sub-score
Change From Baseline in Mean Arterial Pressure
Time to First Occurrence of Hypertension
Rate of Progression of CKD Measured by Annualized eGFR Slope
05
Results
Primary endpoints met
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