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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

Tracking Information
First Submitted Date October 13, 2014
First Posted Date November 25, 2014
Last Update Posted Date June 14, 2017
Actual Study Start Date September 1, 2014
Actual Primary Completion Date December 9, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 24, 2014)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02301026 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 24, 2014)
  • Adverse drug reactions [ Time Frame: 12 month ]
  • 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
  • ESA (use of ESA and dose) [ Time Frame: 12 month ]
    Use of ESA and dose
  • Blood Transfusion (Number of blood transfusions) [ Time Frame: 12 month ]
    Number of blood transfusions
  • IV iron dose (Total needed dose) [ Time Frame: 12 month ]
    Total needed dose
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 24, 2014)
Nurse hours (time spend per treatment) [ Time Frame: 12 month ]
Nurse time spend per treatment
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title A Non-interventional Study of Diafer in Subjects With CKD on Haemodialysis for Treatment of Iron Deficiency
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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Anaemia in Chronic Kidney Disease
Intervention Drug: 5% Iron Isomaltoside 1000
Administered according to local routines and product labeling in doses at the doctors discretion
Other Name: Diafer®
Study Groups/Cohorts Not Provided
Publications * Mikhail AI, Schön 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 1, 2016)
209
Original Estimated Enrollment
 (submitted: November 24, 2014)
200
Actual Study Completion Date December 9, 2016
Actual Primary Completion Date December 9, 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02301026
Other Study ID Numbers Diafer-NIS-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pharmacosmos A/S
Study Sponsor Pharmacosmos A/S
Collaborators BioStata
Investigators
Study Chair: Sylvia Simon Pharmacosmos A/S
PRS Account Pharmacosmos A/S
Verification Date April 2017