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

• Status: Completed
• Trial end date: 2016-12-09
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacosmos A/S
• Collaborator: BioStata
• Treatments: Ferric Compounds; Iron; Iron isomaltoside 1000

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