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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000548639

Acronym

D-IDENTIFY

Enrollment

Registered

2014-05-22

Start date

2014-04-03

Completion date

2015-01-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

200mg Ferric carboxymaltose, intravenous, single dose

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

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)

Outcome results