EUCTR2009-014351-72-SK
Active, not recruiting
Phase 1
A single-center, randomized, single-blind study in parallel groups to evaluate the efficacy and safety of a new intravenous iron HES preparation as compared to intravenous iron dextran (Cosmofer®) in EPO (erythropoietin) naïve patients suffering from anemia
Serumwerk Bernburg0 sites50 target enrollmentSeptember 8, 2010
DrugsCosmofer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Serumwerk Bernburg
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •5\.1 Inclusion criteria
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •1\. Patients suffering from anemia (females with a hemoglobin in the range from 9\-12 g/dl and males in the range
- •from 9\-13,5 g/dl).
- •2\. Age in the range of 18\-75 years inclusive at visit 2 (baseline).
- •3\. Patients suffering from CKD for at least six months
- •4\. Females of child bearing potential with a safe method of contraception for the full study period
- •5\. Patients must give written informed consent before any study specific assessment is performed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •5\.2 Exclusion criteria
- •A patient must not be recruited in this study if at least one single criterion of the subsequent list os fulfilled:
- •1\. Females of child bearing potential without a safe method of contraception for the full study period
- •2\. Pregnant or nursing (lactating) women
- •3\. no EPO therapy during the last three months
- •4\. inpatients for any reason
- •5\. acute or chronic intoxication
- •6\. renal failures in traumatic patients
- •7\. any exclusion criteria from the CosmoFer SPC:
- •anemia caused by non\-iron deficiency
Outcomes
Primary Outcomes
Not specified
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