A Non-interventional Study of Diafer in Subjects With CKD on Haemodialysis for Treatment of Iron Deficiency
DINO
1 other identifier
observational
209
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2014
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 13, 2014
CompletedFirst Posted
Study publicly available on registry
November 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2016
CompletedJune 14, 2017
April 1, 2017
2.3 years
October 13, 2014
June 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Hb (Change in Hb compared to baseline at 3 months intervals)
Change in Hb compared to baseline at 3 months intervals
12 month
Secondary Outcomes (5)
Adverse drug reactions
12 month
Adverse Events
12 month
ESA (use of ESA and dose)
12 month
Blood Transfusion (Number of blood transfusions)
12 month
IV iron dose (Total needed dose)
12 month
Other Outcomes (1)
Nurse hours (time spend per treatment)
12 month
Interventions
Administered according to local routines and product labeling in doses at the doctors discretion
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmacosmos A/Slead
- BioStatacollaborator
Study Sites (2)
Heleneholmsdialysen
Malmo, 214 30, Sweden
Morriston Hospital, Renal Department
Swansea, Wales, SA6 6NL, United Kingdom
Related Publications (1)
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.
PMID: 30630452DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Sylvia Simon
Pharmacosmos A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2014
First Posted
November 25, 2014
Study Start
September 1, 2014
Primary Completion
December 9, 2016
Study Completion
December 9, 2016
Last Updated
June 14, 2017
Record last verified: 2017-04