A Non-interventional Study of Diafer in Subjects With CKD on Haemodialysis for Treatment of Iron Deficiency

Study Overview
=================
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.

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

Conditions
-----------------
Anaemia in Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: 5% Iron Isomaltoside 1000


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 5% Iron Isomaltoside 1000|Administered according to local routines and product labeling in doses at the doctors discretion|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb (Change in Hb compared to baseline at 3 months intervals) | Change in Hb compared to baseline at 3 months intervals | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reactions |  | 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 | 12 month | 
| ESA (use of ESA and dose) | Use of ESA and dose | 12 month | 
| Blood Transfusion (Number of blood transfusions) | Number of blood transfusions | 12 month | 
| IV iron dose (Total needed dose) | Total needed dose | 12 month |