Iron Deficiency Anaemia Clinical Trial
Official title:
A Non-interventional Study of the Time to Relapse of Iron Deficiency Anaemia After Standard Treatment With the Intravenous Iron Monofer® (10% Iron Isomaltoside 1000)
Verified date | March 2019 |
Source | Pharmacosmos A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective is to monitor and quality assure the efficacy, including effects on quality of life, and safety of Monofer® in Chronic Kidney Disease and Inflammatory Bowel Disease patient populations when Monofer® is used according to the Monofer® label (Summary of Product Characteristics, SPC) in current clinical practice and where standard routines are being followed.
Status | Completed |
Enrollment | 359 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients diagnosed with iron deficiency anaemia as a consequence of CKD or IBD (on the basis of local definition or clinical judgement), treated on the doctor's discretion with Monofer® as standard treatment according to current practice Exclusion Criteria: - Patients diagnosed with both CKD and IBD |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Devon and Exeter Hospital NHS Foundation Trust | Exeter |
Lead Sponsor | Collaborator |
---|---|
Pharmacosmos UK Ltd | BioStata |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to relapse of iron deficiency anaemia | From screening until 12 months | ||
Secondary | Change in scores for fatigue symptoms | Immediately before to earliest 4 weeks after each treatment course during 12 months | ||
Secondary | Change in anaemia-related blood parameter levels (haemoglobin, iron parameters) | Immediately before to earliest 4 weeks after each treatment course during 12 months | ||
Secondary | IV iron dose (total needed dose per treatment course) | From screening until 12 months | ||
Secondary | Number and seriousness of Adverse Drug Reactions | From screening until 12 months |
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