Effects of iron deficiency and its treatment on fibroblast growth factor 23 (FGF23) in patients treated with chronic haemodialysis therapy.

Phase 4

Completed

• Conditions: End stage kidney disease; Haemodialysis; Iron deficiency; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12614000548639
• Lead Sponsor: Eastern Health Integrated Renal Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Aged 18-90 years
2. Receiving chronic thrice weekly haemodialysis therapy for >3 months
3. Requiring IV iron therapy based on current guidelines

Exclusion Criteria

1. Inability to give informed consent
2. Active infection
3. Evidence of malignancy
4. Blood transfusion within preceding 4 weeks
5. Initial haemoglobin < 85 g/L
6. Previous hypersensitivity to intravenous iron sucrose or ferric carboxymaltose
7. Recent introduction or change in dose of erythropoietin agents, phosphate binders, vitamin D analogues or cinacalcet (within last 4 weeks)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline to peak intact FGF23 serum concentration [Days 2, 7, 21 and 42 post administration of iron therapy]

Secondary Outcome Measures

Name	Time	Method
Change in serum 1,25 dihydroxyvitamin D concentration[Days 2, 7, 21 and 42 post administration of iron therapy];Change in serum phosphate concentration[Days 2, 7, 21 and 42 post administration of iron therapy];Change in serum parathyroid hormone concentration[Days 2, 7, 21 and 42 post administration of iron therapy]