An observational study in Anaemia in Chronic Kidney Disease, sponsored by Pharmacosmos A/S. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-14.
Sponsored by Pharmacosmos A/S · Observational
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 209 is close to the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Pharmacosmos A/S is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients ≥ 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 6 months while being on dialysis.
Exclusion Criteria:
Administered according to local routines and product labeling in doses at the doctors discretion
Also known as: Diafer®
Hb (Change in Hb compared to baseline at 3 months intervals)
Change in Hb compared to baseline at 3 months intervals
Time frame: 12 month
Adverse drug reactions
Time frame: 12 month
Adverse Events
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
Time frame: 12 month
ESA (use of ESA and dose)
Use of ESA and dose
Time frame: 12 month
Blood Transfusion (Number of blood transfusions)
Number of blood transfusions
Time frame: 12 month
IV iron dose (Total needed dose)
Total needed dose
Time frame: 12 month
Nurse hours (time spend per treatment)
Nurse time spend per treatment
Time frame: 12 month
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pharmacosmos A/S