Study identification

EU PAS number

EUPAS7008

Study ID

28188

Official title and acronym

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 (Diafer-NIS-06)

DARWIN EU® study

No

Study countries

Sweden
United Kingdom

Study description

A prospective 12 months multicentre observational study with systematic monitoring of anaemia-related parameters and safety in relation to intravenous Diafer® therapy according to local clinic standards. The primary objective of the study is to monitor initiated Diafer® therapy administered according to hospital practice and the product labelling in routine clinical practice in haemodialysis patients with chronic kidney disease. The primary efficacy outcome is haemoglobin concentration compared to baseline and key secondary endpoints include iron dose, erythropoietin-stimulating agent dose, and haematinics. Safety will be evaluated by the number and seriousness of adverse drug reactions and adverse events of special interest.

Study status

Finalised
Research institutions and networks

Institutions

Diaverum, Heleneholmsdialysen
Sahlgrenska University Hospital Gothenburg, Sweden, Morriston Hospital Swansea, Wales, UK, Royal Devon&Exeter Hospital Exeter, Devon, UK, Norrland University Hospital Umeå, Sweden

Contact details

Staffan Schön

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pharmacosmos A/S
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable