Anaemia in Chronic Kidney Disease Clinical Trial
Official title:
A Non-interventional Study of Diafer (5% Iron Isomaltoside 1000) Administered According to Standard Hospital Practice and Product Labelling in Subjects With Chronic Kidney Disease on Haemodialysis for Treatment of Iron Deficiency
The purpose of the study is to monitor initiated Diafer® therapy administered according to hospital practice and the product labeling in routine clinical practice in haemodialysis patients with Chronic Kidney Disease.
Parenteral iron is the iron treatment of choice for haemodialysis (HD) patients with Chronic
Kidney Disease (CKD), who may suffer from absolute iron deficiency due to continuous blood
losses and/or functional iron deficiency due to erythropoiesis stimulating agent treatment
or impaired release from iron stores.
Much evidence indicates that adequate iron supply is necessary to achieve optimal responses
to ESAs and thereby potentially avoid ESA induced ADRs.
Pharmacosmos has been working with dialysis providers for many years and identified a
medical need for a new safe and cost-effective low dose intravenous (IV) iron that can be
administered frequently. Diafer® is a new low dose iron formulation based on iron
isomaltoside 1000, with doses restricted to maximum 200 mg iron pr. injection. No test dose
is needed and Diafer® may be administered as a push injection.
The primary objective of the study is to monitor initiated Diafer® therapy administered
according to hospital practice and the product labeling in routine clinical practice in HD
patients with CKD. The scientific rationale being to fulfil a need for systematic
information/auditing on applied practice including long term experience with the use of IV
iron in the HD setting. This information will provide an evidence base for optimised
treatment procedures.
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