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Study 1 of 29 for search of: | Macedonia, The Former Yugoslav Republic of |
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Sponsors and Collaborators: |
Novartis Hexal Biotech ForschungsGmbH |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00632125 |
Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among CKD subjects receiving HX575 epoetin alfa i.v.
Condition | Intervention | Phase |
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Chronic Kidney Disease |
Drug: HX575 recombinant human erythropoietin alfa |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Post-Authorization Safety Study to Prospectively Monitor the Incidence of Relevant Drug-Related Adverse Events and EPO-Related Lack of Efficacy Among CKD Subjects Receiving HX575 Recombinant Human Erythropoietin Alfa i.v. |
Estimated Enrollment: | 1500 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: HX575 recombinant human erythropoietin alfa
HX575 epoetin alfa i.v. will be administered according to the SmPC
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Karsten Roth, Dr. | +4989613670191 | karsten.roth@sandoz.com |
Study Chair: | Karsten Roth, Dr | Hexal Biotech ForschungsGmbH |
Responsible Party: | Sandoz Biopharmaceuticals Development ( Hexal Biotech ForschungsGmbH ) |
Study ID Numbers: | 2006-66-INJ-14 |
Study First Received: | February 29, 2008 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00632125 |
Health Authority: | Austria: Federal Office for Safety in Health Care; Germany: Ministry of Health; Italy: The Italian Medicines Agency; Spain: Ministry of Health; United Kingdom: National Health Service |
CKD subjects with or without dialysis treatment |
Epoetin Alfa Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |