This trial is active, not recruiting.

Condition anaemia in chronic kidney disease
Treatment 5% iron isomaltoside 1000
Sponsor Pharmacosmos A/S
Collaborator BioStata
Start date September 2014
End date December 2016
Trial size 209 participants
Trial identifier NCT02301026, Diafer-NIS-06


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Hb (Change in Hb compared to baseline at 3 months intervals)
time frame: 12 month

Secondary Outcomes

Adverse drug reactions
time frame: 12 month
Adverse Events
time frame: 12 month
ESA (use of ESA and dose)
time frame: 12 month
Blood Transfusion (Number of blood transfusions)
time frame: 12 month
IV iron dose (Total needed dose)
time frame: 12 month

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - HD patients ≥ 18 years of age in a stable phase of CKD as judged by the investigator - Patients must have been on HD > 3 months - Patients must have received at least one dose of iron sucrose treatment within the last 6 months Exclusion Criteria: - Diafer® contraindications - Patient not able to give informed consent - Significant disease not related to CKD and likely to impact study results as evaluated by investigator - Inability to estimate retrospective baseline data - Planned change of iron dosing protocol or routines around iron administration during the study

Additional Information

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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Pharmacosmos A/S.