Anemia Clinical Trial
Official title:
Investigation of the Mechanisms for the Development of Hypophosphataemia Following Administration of Intravenous Iron in Patients With Severe Anaemia
Verified date | August 2020 |
Source | Belfast Health and Social Care Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Anaemia (low haemoglobin levels) can develop in a number of conditions, including chronic kidney disease (CKD) and intestinal conditions (e.g. inflammatory bowel disease, intestinal failure). Intravenous iron can be given to patients with these conditions to help correct their aneaemia. However, intravenous iron has been associated with the development of low phosphate levels - hypophophosphataemia. The aim of this study is to determine potential causes of hypophosphataemia following administration of intravenous iron.
Status | Enrolling by invitation |
Enrollment | 40 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: For Patients - aged 18 years or older - previously diagnosed with intestinal failure or advanced CKD - have anaemia requiring administration of intravenous iron - be able to adequately speak and understand English - Have capacity to give written informed consent For Healthy Volunteers - aged 18 years or more - be able to adequately speak and understand English - have capacity to give written informed consent Exclusion Criteria: For patients - have dialysis-dependent CKD - participation in any other study which will affect results of the current study For Healthy Volunteers - have CKD (eGFR <60 mls/min/1.73^2) - history of any form of metabolic bone disease - Participation in any other study which will affect the results of the current study |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Belfast Health and Social Care Trust | Belfast |
Lead Sponsor | Collaborator |
---|---|
Belfast Health and Social Care Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FGF23 levels before and after intravenous iron | Measurement of FGF23 levels in patients with CKD before and after intravenous iron administration | 8 weeks | |
Secondary | FGF23 levels in patients with CKD and healthy volunteers | Comparison of measured FGF23 levels in patients with CKD and healthy volunteers | 1 week | |
Secondary | Characterisation of pre-analytical factors affecting FGF23 levels | To examine the effect of delayed separation and fasting vs non-fasting on FGF23 levels | 1 week |
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