NCT00666835

Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients

Randomized, Double-blind, Multicenter, Parallel-group, Equivalence Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 478 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomized, multicenter, parallel-group, equivalence study involving about 462 clinically stable hemodialysis patients aged 18 years or above suffering from anemia and treated previously with a stable dose of ERYPO® intravenously.

Detailed description

The primary objective of this Phase III study is the evaluation of therapeutic equivalence of HX575 Hexal AG and a comparator of epoetin alfa, ERYPO® in the maintenance intravenous treatment of renal anemia. Efficacy, dosage and safety of HX575 Hexal AG in the long-term treatment were assessed.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	HX575 epoetin alfa Hexal AG	HX575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin
DRUG	ERYPO®, Janssen-Cilag	Solution for i.v. injection

Timeline

• Start date: 2004-04-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2008-04-25
• Last updated: 2023-07-03
• Results posted: 2017-08-02

Locations

54 sites across 2 countries: Austria, Germany