Clinical trial NCT02301026: A Non-interventional Study of Diafer in Subjects With CKD on Haemodialysis for Treatment of Iron Deficiency
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaemia in Chronic Kidney Disease
Lead sponsor: Pharmacosmos A/S
Sponsor class: INDUSTRY
Collaborators: name: BioStata
First posted: 2014-11-25
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hb (Change in Hb compared to baseline at 3 months intervals)
timeFrame: 12 month
Secondary outcomes:
measure: Adverse drug reactions
timeFrame: 12 month
measure: Adverse Events
timeFrame: 12 month
measure: ESA (use of ESA and dose)
timeFrame: 12 month
measure: Blood Transfusion (Number of blood transfusions)
timeFrame: 12 month
measure: IV iron dose (Total needed dose)
timeFrame: 12 month
Other outcomes:
measure: Nurse hours (time spend per treatment)
timeFrame: 12 month
Locations:
city: Malmö
country: Sweden
facility: Heleneholmsdialysen
city: Swansea
country: United Kingdom
facility: Morriston Hospital, Renal Department
state: Wales
Study officials:
affiliation: Pharmacosmos A/S
name: Sylvia Simon
role: STUDY_CHAIR
References:
citation: Mikhail AI, Schon S, Simon S, Brown C, Hegbrant JBA, Jensen G, Moore J, Lundberg LDI. A prospective observational study of iron isomaltoside in haemodialysis patients with chronic kidney disease treated for iron deficiency (DINO). BMC Nephrol. 2019 Jan 10;20(1):13. doi: 10.1186/s12882-018-1159-z.