Trials / Terminated
TerminatedNCT00701714
Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 337 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, controlled, double-blind, multicenter multinational safety study involving about 300 predialysis patients aged 18 years or above suffering from anemia. Symptomatic anemia will be corrected by s.c. application of EPO HEXAL or ERYPO® in order to achieve a hemoglobin target range of 10.0 -12.0 g/dL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HX575 recombinant human erythropoietin alfa | Solution for injection (s.c.) |
| DRUG | ERYPO | Solution for injection (s.c.) |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2009-07-01
- Completion
- 2010-01-01
- First posted
- 2008-06-19
- Last updated
- 2018-02-05
- Results posted
- 2018-02-05
Locations
123 sites across 10 countries: Austria, Bulgaria, Czechia, France, Germany, India, Poland, Romania, Russia, Slovakia
Source: ClinicalTrials.gov record NCT00701714. Inclusion in this directory is not an endorsement.