A Non-interventional Study of Diafer in Subjects With CKD on Haemodialysis for Treatment of Iron Deficiency (DINO)
|ClinicalTrials.gov Identifier: NCT02301026|
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment|
|Anaemia in Chronic Kidney Disease||Drug: 5% Iron Isomaltoside 1000|
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.
|Study Type :||Observational|
|Actual Enrollment :||209 participants|
|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|
|Actual Study Start Date :||September 1, 2014|
|Actual Primary Completion Date :||December 9, 2016|
|Actual Study Completion Date :||December 9, 2016|
- Drug: 5% Iron Isomaltoside 1000
Administered according to local routines and product labeling in doses at the doctors discretionOther Name: Diafer®
- Hb (Change in Hb compared to baseline at 3 months intervals) [ Time Frame: 12 month ]Change in Hb compared to baseline at 3 months intervals
- Adverse drug reactions [ Time Frame: 12 month ]
- Adverse Events [ Time Frame: 12 month ]AEs of special interest defined as hypersensitivity symptoms such as urticaria, oedema, bronchospasm, hypotension, cardiorespiratory arrest, syncope, unresponsiveness or loss of consciousness at pre-specified time points in relation to administration of study drug
- ESA (use of ESA and dose) [ Time Frame: 12 month ]Use of ESA and dose
- Blood Transfusion (Number of blood transfusions) [ Time Frame: 12 month ]Number of blood transfusions
- IV iron dose (Total needed dose) [ Time Frame: 12 month ]Total needed dose
- Nurse hours (time spend per treatment) [ Time Frame: 12 month ]Nurse time spend per treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301026
|Malmö, Sweden, 214 30|
|Morriston Hospital, Renal Department|
|Swansea, Wales, United Kingdom, SA6 6NL|
|Study Chair:||Sylvia Simon||Pharmacosmos A/S|