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CinnaPoietin vs Eprex in Anemia of ESRD
NCT03408639Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2016
- Primary completion
- Jul 2017
- Countries
- 1
- Sponsor
- CinnaGen
- Modality
- Erythropoietins, Colony Stimulating Factors
- Drugs
- epoetin beta
- Conditions
- anemia of chronic kidney disease (CKD-A)
01
Overview
Phase 3, randomised, double-blind trial of epoetin beta in anemia of chronic kidney disease (CKD-A) (2 arms), sponsored by CinnaGen. Primary endpoints: Mean Hemoglobin Change Level During the Last Four Weeks of Treatment and Mean Weekly Epoetin Dosage Per kg Body Weight. Started Jun 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
CinnaPoietin
CinnaPoietin (Epoetin beta) + Nephrovit + Vitamin B12
Eprex
Eprex (Epoetin alfa) + Nephrovit + Vitamin B12
03
Who it enrols
Adult ESRD patients on hemodialysis for at least 3 months with Hb 8-11.5 g/dl and adequate iron stores. Excludes uncontrolled hypertension, active bleeding, malignancy, and severe heart failure.
04
Endpoints
Primary
Mean Hemoglobin Change Level During the Last Four Weeks of Treatment
Mean Weekly Epoetin Dosage Per kg Body Weight
Secondary
Proportion of Patients With Any Permanent or Transient Dose Change
Proportion of Patients With Any Hb Measurement Outside the Target Range (10-12 g/dl)
Proportion of Patients Needed Blood Transfusions
Proportion of Patients With Treatment Success
Proportion of Patients With Maintenance Success
Percentage of Patients With Hb Measurements More Than 10.0 g/dl
Percentage of Patients With Hematocrit Measurements More Than 30%
Incidence of Hb Levels Above 13 g/dl
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