Anemia caused by terminal renal insufficiency
Conditions
Interventions
Product Name: Epoetin STADA
Product Code: n.a.
Pharmaceutical Form: Solution for injection
INN or Proposed INN: n.a.
CAS Number: 604802-70-2
Current Sponsor code: n.a.
Other descriptive name: CAS name
Sponsors
STADA R&D GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • myelodysplastic syndrome • detectable anti-epoetin antibodies • presence of malignant tumors • pregnancy or lactation period in female patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To gather data regarding the safety of Epoetin STADA (with a particular focus on the formation of anti-epoetin antibodies) when administered intravenously for maintaining the hemoglobin concentration in anemic patients with end-stage renal failure on chronic hemodialysis;Secondary Objective: To provide supportive information regarding the efficacy of Epoetin STADA under open, non-controlled conditions;Primary end point(s): • evaluation of adverse events • occurrence of anti-epoetin antibodies | — |
Countries
Germany
Outcome results
None listed