Status:
COMPLETED
A Non-interventional Study of Diafer in Subjects With CKD on Haemodialysis for Treatment of Iron Deficiency
Lead Sponsor:
Pharmacosmos A/S
Collaborating Sponsors:
BioStata
Conditions:
Anaemia in Chronic Kidney Disease
Eligibility:
All Genders
18+ years
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 Chroni...
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 fu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 9 2016
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT02301026
Start Date
September 1 2014
End Date
December 9 2016
Last Update
June 14 2017
Active Locations (2)
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1
Heleneholmsdialysen
Malmo, Sweden, 214 30
2
Morriston Hospital, Renal Department
Swansea, Wales, United Kingdom, SA6 6NL