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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00666835 |
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.
Condition | Intervention | Phase |
---|---|---|
Anemia |
Drug: HX 575 Solution for i.v. injection Drug: ERYPO®, Janssen-Cilag, Germany |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Multicenter, Parallel-Group, Equivalence Study to Evaluate the Efficacy and Safety of HX 575 vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients |
Enrollment: | 462 |
Study Start Date: | April 2004 |
Study Completion Date: | January 2006 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
HX575
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Drug: HX 575 Solution for i.v. injection
HX 575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin
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2: Active Comparator |
Drug: ERYPO®, Janssen-Cilag, Germany
Solution for i.v. injection
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The primary objective of this Phase III study is the evaluation of therapeutic equivalence of HX575 and a comperator epoetin alfa in the maintenance intravenous treatment of renal anemia. Efficacy, dosage and safety of HX575 in the long-term treatment were assessed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Marianne Haag-Weber, Prof. | Dialysezentrum Straubing, Germany |
Responsible Party: | Hexal AG ( Hexal AG ) |
Study ID Numbers: | 2003-29-INJ-9 |
Study First Received: | April 23, 2008 |
Last Updated: | April 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00666835 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Austria: Federal Office for Safety in Health Care |
Treatment of anemia in hemodialysis patients |
Epoetin Alfa Hematologic Diseases Anemia |