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

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

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.

Study Overview

• Status: Completed
• Conditions: Anaemia in Chronic Kidney Disease
• Intervention / Treatment: Drug: 5% Iron Isomaltoside 1000

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 Type: Observational
• Enrollment (Actual): 209

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden, 214 30
    • Heleneholmsdialysen
• United Kingdom
  • Wales
    • Swansea, Wales, United Kingdom, SA6 6NL
      • Morriston Hospital, Renal Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nurse hours (time spend per treatment)	Nurse time spend per treatment	12 month

Collaborators and Investigators

• Sponsor: Pharmacosmos A/S
• Collaborators: BioStata
• Investigators: Study Chair: Sylvia Simon, Pharmacosmos A/S

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): December 9, 2016
• Study Completion (Actual): December 9, 2016

Study Registration Dates

• First Submitted: October 13, 2014
• First Submitted That Met QC Criteria: November 24, 2014
• First Posted (Estimate): November 25, 2014

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Hematinics; Iron isomaltoside 1000
• Other Study ID Numbers: Diafer-NIS-06