Trials / Completed
CompletedNCT01576341
HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)
Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of HX575 Epoetin Alfa in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Patients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 417 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HX575 epoetin alfa (Sandoz) | Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia. |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2014-10-01
- Completion
- 2015-06-01
- First posted
- 2012-04-12
- Last updated
- 2017-06-19
- Results posted
- 2017-06-19
Locations
50 sites across 7 countries: Germany, Italy, Poland, Romania, Russia, Turkey (Türkiye), Ukraine
Source: ClinicalTrials.gov record NCT01576341. Inclusion in this directory is not an endorsement.