Diafer in CKD on Haemodialysis for treatment of iron deficiency
Research type
Research Study
Full 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
IRAS ID
159035
Contact name
Claes C Strom
Contact email
Sponsor organisation
Pharmacosmos A/S
Research summary
This is a prospective multicentre observational study with systematic monitoring of anaemia-related parameters and safety in relation to intravenous Diafer® therapy according to local clinic standards. The purpose of the study is to look at how the Diafer® treatment is affecting patients’ blood count and other laboratory values related to their iron deficiency and how well the treatment is tolerated every 3 months over a 12 month period.
Patients must be = 18 years of age with chronic kidney disease (CKD) who have been on HD > 3 months and have received at least one dose of iron sucrose treatment within the last months from study start while being on dialysis.. Data will be collected from the patient notes and laboratory results available at the sites. A total of 200 patients will be included in the study with approximately 50 patients recruited per site. Patient recruitment at the individual sites will be consecutive. Both Sweden and the UK will participate, with 2 NHS sites to be set up in England and Wales. The total duration of the study is approximately 18 months, which includes a 6 months enrolment period and a 12 months prospective observation period.REC name
East of Scotland Research Ethics Service REC 2
REC reference
14/ES/1075
Date of REC Opinion
23 Sep 2014
REC opinion
Favourable Opinion