Investigation of Hypophosphataemia Following Intravenous Iron

NCT04502784 | Unknown

• 1 other identifier: 18195BR-SS
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypophosphatemia; Chronic Kidney Diseases; Intestinal Disease; Anemia

Outcome Measures

Primary Outcomes (1)

• FGF23 levels before and after intravenous iron

  Measurement of FGF23 levels in patients with CKD before and after intravenous iron administration

  8 weeks

Secondary Outcomes (2)

• FGF23 levels in patients with CKD and healthy volunteers

  1 week

• Characterisation of pre-analytical factors affecting FGF23 levels

  1 week

Study Arms (3)

Chronic Kidney Disease

This group will consist of 10 patients who have previously been diagnosed with chronic kidney disease and are receiving intravenous iron due to anaemia.

Intestinal failure

This group will consist of 10 patients who have previously been diagnosed with intestinal conditions and are receiving intravenous iron due to anaemia.

Healthy Volunteers

This group will consist of 20 healthy volunteers. This group will act as a comparator for the CKD and intestinal failure groups.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with intestinal failure or CKD will be recruited from iron infusion clinics, which are based in secondary care. Healthy Volunteers will be recruited from laboratory staff from within the Belfast Health and Social Care Trust

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead

Study Sites (1)

Belfast Health and Social Care Trust

Belfast, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, EDTA plasma, and urine samples will be collected and stored for batch analysis.

MeSH Terms

Conditions

Hypophosphatemia; Renal Insufficiency, Chronic; Intestinal Diseases; Anemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Brona Roberts

  Beflast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 6, 2020
• Study Start: October 7, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)