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

Completed

• Conditions: Anaemia in Chronic Kidney Disease

• Registration Number: NCT02301026
• Lead Sponsor: Pharmacosmos A/S

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.

Study Timeline

• Study Start: 2014-09-01
• Study First Submitted: 2014-10-13
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-25
• Primary Completion: 2016-12-09
• Study Completion: 2016-12-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hb (Change in Hb compared to baseline at 3 months intervals)	12 month	Change in Hb compared to baseline at 3 months intervals

Secondary Outcome Measures

Name	Time	Method
Adverse drug reactions	12 month
Adverse Events	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)	12 month	Use of ESA and dose
Blood Transfusion (Number of blood transfusions)	12 month	Number of blood transfusions
IV iron dose (Total needed dose)	12 month	Total needed dose

Trial Locations

Locations (2)

Morriston Hospital, Renal Department; 🇬🇧 Swansea, Wales, United Kingdom

Heleneholmsdialysen; 🇸🇪 Malmö, Sweden