Continuos versus periodic intravenous iron supplementation in maintenance hemodialysis patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003914-15-AT

Enrollment

140

Registered

2014-05-27

Start date

2014-06-17

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Anemia and iron deficiency in patients with end-stage renal disease on maintenance dialysis

Interventions

Trade Name: Ferinject Product Name: Ferinject Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: FERRIC CARBOXYMA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients with anemia and end-stage renal disease on maintenance hemodialysis • Hemoglobin = 8,5 g/dl • Ferritin 18 years • Written informed consent 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: • Hemoglobin 5 mg/dl, antibiotic treatment – except prophylactic antibiotic treatment) • Patients on oral iron therapy at study inclusion • Simultaneous participation in another clinical trial • Active bleeding • Surgical treatment within four weeks prior study inclusion • Mental disorder • Blood transfusion within four weeks prior study inclusion • Drug or alcohol abuse • Asthma bronchiale • Atopic disease • Eczema

Design outcomes

Primary

Measure	Time frame
Main Objective: Ferric carboxymaltose (Ferinject) in comparison to iron sucrose (Venofer) is non inferior in maintaining the target hemoglobin-level (Hb 10-12 g/dl);Secondary Objective: Ferritin, transferrin, transferrin saturation, consumption of erythropoiesis-stimulating agent (ESA);Primary end point(s): Hemoglobin;Timepoint(s) of evaluation of this end point: Study week 40	—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Study week 40;Secondary end point(s): Ferritin, transferrin, transferrin saturation, consumption of erythropoiesis-stimulating agent (ESA)	—

Countries

Austria

Contacts

Public ContactNephrologie und Dialyse

Medizinische Universität Wien, Klinik für Innere Medizin III, Klin. Abteilung für Nephrologie und Dialyse

gere.sunder-plassmann@meduniwien.ac.at+43014040043910

Outcome results

None listed

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