Intravenous iron in patients with heart failure and reduced ejection fraction (HFREF) plus iron deficiency: Effects upon phosphate and FGF23 metabolism - Iron Turtle

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004147-37-DE

Enrollment

Registered

2016-11-24

Start date

2017-01-31

Completion date

Unknown

Last updated

2018-01-08

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

Conditions

Systolic heart failure (heart failure with reduced ejection fraction, HFREF) + iron deficiency with serum ferritin <100 µg/l or 100 – 299 µg/L when transferrin saturation (TSAT) is <20%

Interventions

Trade Name: Ferinject Pharmaceutical Form: Solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Written informed consent. - Age > 18 yrs - Symptomatic HFREF (LV ejection fraction 60 ml/min/1,73 m3 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24

Exclusion criteria

Exclusion criteria: - Known hypersensitivity to ferric carboxymaltose or any constituents of the formulation, - Plasma Phosphate < 2.5 mg/dL at screening, - Renal replacement therapy/transplantation, - Pregnancy or lactation - iron substitution therapy or erythropoetin (epo) therapy within 6 weeks before - participation in another clinical trial with an experimental drug - expectation of missing compliance - alcohol or drug abuse - The subject is mentally or legally incapacitated - patients who are in a relationship of dependence or in a working relationship to the sponsor, the investigator or his representative

Design outcomes

Primary

Measure	Time frame
Main Objective: Effects of ferric carboxymaltose single HD (1000 mg) infusion upon FGF23 in patients with isolated HFREF compared to patients with HFREF+CKD (all pts with iron deficiency). This study aims at identification of the optimal target population for a follow-up (“main”) study.;Secondary Objective: To investigate the following parameters: - Serum and Urine phosphate - serum calcitriol - serum S-klotho;Primary end point(s): Changes in blood intact and c-term FGF23 after FCM 1000 mg i.v. iron;Timepoint(s) of evaluation of this end point: 4 weeks	—

Measure

Time frame

Main Objective: Effects of ferric carboxymaltose single HD (1000 mg) infusion upon FGF23 in patients with isolated HFREF compared to patients with HFREF+CKD (all pts with iron deficiency). This study aims at identification of the optimal target population for a follow-up (“main”) study.;Secondary Objective: To investigate the following parameters: - Serum and Urine phosphate - serum calcitriol - serum S-klotho;Primary end point(s): Changes in blood intact and c-term FGF23 after FCM 1000 mg i.v. iron;Timepoint(s) of evaluation of this end point: 4 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): - additional serum and urinary biomarkers belonging to CKD-MBD (phosphate and vitamin D metabolism) - urinary markers of tubular damage - Inflammatory mediators (IL1, IL6, TNF alpha hsCRP) - phosphate level < 1,25 mg/dL;Timepoint(s) of evaluation of this end point: 4 weeks	—

Countries

Germany

Contacts

Public ContactCTC-A

RWTH Aachen

iviol@ukaachen.de00492418037864

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026