Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of HX575 Epoetin Alfa vs. US Licensed Epoetin Alfa (Epogen®/Procrit®) in the Treatment of Anemia Associated With Chronic Kidney Disease (ACCESS)

NCT01693029 Phase 3 COMPLETED Results posted

The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.

Details

Lead sponsor	Sandoz
Phase	Phase 3
Status	COMPLETED
Enrolment	435
Start date	2012-09
Completion	2015-03

Conditions

• Anemia
• Chronic Kidney Disease (CKD)

Interventions

• HX575 epoetin alfa
• US-licensed epoetin alfa

Primary outcomes

• Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28) — Week -4 to Day1 and Week 21-28
  Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
• Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28) — Week -4 to Day1 and Week 21-28
  Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .

Countries

United States