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

NCT ID: NCT02301026

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 209 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-01
• Study Completion Date: 2016-12-09

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.

Conditions

Anaemia in Chronic Kidney Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

5% Iron Isomaltoside 1000

Administered according to local routines and product labeling in doses at the doctors discretion

Intervention Type: DRUG

Other Intervention Names

Diafer®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioStata

INDUSTRY

Sponsor Role: collaborator

Pharmacosmos A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvia Simon

Role: STUDY_CHAIR

Pharmacosmos A/S

Locations

Heleneholmsdialysen

Malmo, , Sweden

Morriston Hospital, Renal Department

Swansea, Wales, United Kingdom

Countries

Sweden; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30630452 (View on PubMed)

Other Identifiers

Diafer-NIS-06

Identifier Type: -

Identifier Source: org_study_id