CompletedPhase 4ACTRN12614000548639

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

Sponsor

Eastern Health Integrated Renal Service

Enrollment

40 participants

Start Date

Apr 3, 2014

Study Type

Interventional

Conditions

Haemodialysis

Summary

The goal of this randomised controlled trial is to examine the effects of iron deficiency and compare its correction with either IV ferric carboxymaltose or iron sucrose on intact fibroblast growth factor 23 (FGF23)concentrations in individuals with end stage kidney disease undergoing chronic haemodialysis therapy.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Inclusion Criteria3

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

Exclusion Criteria7

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