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

• Conditions: Anemia in chronic kidney disease

• Registration Number: EUCTR2009-014351-72-AT
• Lead Sponsor: Serumwerk Bernburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
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

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
•iron overload
•distrubances in iron metabolism
•excess iron
•asthma
•ekzema
•atopic allergies
•rheumatoid arthritis, acute phase of SLE
•severe liver disease ALT/AST > 4 time UNL
•severe infections
8.severe drug abuse
9.end stage renal disease
10.blood transfusions during the last six months
11.HbA1c>7,5%
12.anticipated medical need for EPO (erythropoietin) treatment during the main study period from baseline to the day 7 (visit 3) or during three months prior the baseline visit.
13.Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Compare efficacy and safety of iron-HES vs Cosmofer (iron dextran);Secondary Objective: Provide short term information of effects after infusion;Primary end point(s): hemoglobin after 7 days