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Clinical Trials/EUCTR2009-014351-72-AT
EUCTR2009-014351-72-AT
Active, not recruiting
Not Applicable

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 anemic patients

Serumwerk Bernburg0 sitesSeptember 16, 2009
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ConditionsAnemia in chronic kidney disease
DrugsCosmofer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anemia in chronic kidney disease
Sponsor
Serumwerk Bernburg
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 16, 2009
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Serumwerk Bernburg

Eligibility Criteria

Inclusion Criteria

  • •5\.1Inclusion 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 30\-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:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •5\.2Exclusion 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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