Evaluation of the Safety of a Formulation Containing Epoetin (Epoetin STADA) Administered Intravenously for the Maintenance Treatment of Renal Anemia: an Open Follow-up Trial. Study code (CRO) 411-54-04-14-0000. - Epoetin STADA, Follow up
- Conditions
- Anemia caused by terminal renal insufficiency
- Registration Number
- EUCTR2004-004401-26-DE
- Lead Sponsor
- STADA R&D GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 620
•male or female hemodialysis patients who have completed the double-blind treatment period of the tri-als 411-54-04-04-0000 (CT-830-04-0002) and 411-54-04-05-0000 (CT-830-04-0003) and who are will-ing to continue for another 28 weeks
•informed consent given in a written form after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug..
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•myelodysplastic syndrome
•detectable anti-epoetin antibodies
•presence of malignant tumors
•pregnancy or lactation period in female patients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method