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

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ClinicalTrials.gov Identifier: NCT02301026
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
BioStata
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Anaemia in Chronic Kidney Disease 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.


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Study Type : Observational
Actual Enrollment : 209 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 1, 2014
Actual Primary Completion Date : December 9, 2016
Actual Study Completion Date : December 9, 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: 5% Iron Isomaltoside 1000
    Administered according to local routines and product labeling in doses at the doctors discretion
    Other Name: Diafer®


Primary Outcome Measures :
  1. Hb (Change in Hb compared to baseline at 3 months intervals) [ Time Frame: 12 month ]
    Change in Hb compared to baseline at 3 months intervals


Secondary Outcome Measures :
  1. Adverse drug reactions [ Time Frame: 12 month ]
  2. Adverse Events [ Time Frame: 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

  3. ESA (use of ESA and dose) [ Time Frame: 12 month ]
    Use of ESA and dose

  4. Blood Transfusion (Number of blood transfusions) [ Time Frame: 12 month ]
    Number of blood transfusions

  5. IV iron dose (Total needed dose) [ Time Frame: 12 month ]
    Total needed dose


Other Outcome Measures:
  1. Nurse hours (time spend per treatment) [ Time Frame: 12 month ]
    Nurse time spend per treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301026


Locations
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Sweden
Heleneholmsdialysen
Malmö, Sweden, 214 30
United Kingdom
Morriston Hospital, Renal Department
Swansea, Wales, United Kingdom, SA6 6NL
Sponsors and Collaborators
Pharmacosmos A/S
BioStata
Investigators
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Study Chair: Sylvia Simon Pharmacosmos A/S

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT02301026     History of Changes
Other Study ID Numbers: Diafer-NIS-06
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Iron
Iron isomaltoside 1000
Ferric Compounds
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics