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

Anaemia in Chronic Kidney Disease Clinical Trial

— DINO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02301026
• Other study ID #: Diafer-NIS-06
• Status: Completed
• Phase: N/A
• First received: October 13, 2014
• Last updated: June 13, 2017
• Start date: September 1, 2014
• Est. completion date: December 9, 2016

Study information

• Verified date: April 2017
• Source: Pharmacosmos A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: December 9, 2016
• Est. primary completion date: December 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anaemia in Chronic Kidney Disease
• Anemia, Iron-Deficiency
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• 5% Iron Isomaltoside 1000
Administered according to local routines and product labeling in doses at the doctors discretion

Locations

Country	Name	City	State
Sweden	Heleneholmsdialysen	Malmö
United Kingdom	Morriston Hospital, Renal Department	Swansea	Wales

Sponsors (2)

Lead Sponsor	Collaborator
Pharmacosmos A/S	BioStata

Countries where clinical trial is conducted

Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nurse hours (time spend per treatment)	Nurse time spend per treatment	12 month
Primary	Hb (Change in Hb compared to baseline at 3 months intervals)	Change in Hb compared to baseline at 3 months intervals	12 month
Secondary	Adverse drug reactions		12 month
Secondary	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
Secondary	ESA (use of ESA and dose)	Use of ESA and dose	12 month
Secondary	Blood Transfusion (Number of blood transfusions)	Number of blood transfusions	12 month
Secondary	IV iron dose (Total needed dose)	Total needed dose	12 month