Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients

Phase 4

Completed

• Conditions: Anemia of Chronic Kidney Disease
• Interventions: Drug: Supplementation of ferric carboxymaltose; Drug: Supplementation of iron sucrose

• Registration Number: NCT02198495
• Lead Sponsor: Medical University of Vienna

Brief Summary

Patients with end-stage kidney disease on maintenance hemodialysis frequently require iron supplementation to compensate for ongoing iron losses, and to maintain hemoglobin levels with or without additional use of erythropoiesis-stimulating agents (ESA).

The investigators aim to compare two different intravenous iron preparations, ferric carboxymaltose and iron sucrose in 140 hemodialysis patients. The investigators primary objective is to assess whether both agents are equally effective to maintain a target haemoglobin within 10-12 mg/dl. The investigators will also measure ferritin, transferrin, transferrin saturation, and how much ESA therapy is administered.

Patients will be randomly assigned to either treatment group and followed in parallel over an active study period of 40 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-23
• Study Start: 2014-09
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

• Signed informed consent
• Male and female patients aged ≥ 18
• Patients with anemia and end stage kidney disease on dialysis
• Hemoglobin ≥ 8,5g/dl
• Ferritin < 1000mg/dl
• TSAT < 50%
• CRP < 5mg/dl

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Exclusion Criteria

• Hemoglobin < 8,5g/dl
• Pregnancy or Nursing
• Known allergic reaction to i.v. iron supplementation or to ingredients of Investigational Medicinal Product (IMP)
• Chronic infections (HIV, Hep B, Hep C)
• Acute infections (CRP>5mg/dl; Antibiotic therapy except for prophylactic use)
• Malignant tumor disease
• Oral iron supplementation at study inclusion
• Participation in a different study at the same time
• Active bleeding issues
• Surgical intervention within the last 4 weeks before study inclusion
• Mental diseases
• Bronchial asthma
• Atopic allergy
• Eczema
• Receipt of red blood cell (RBC) concentrate within the last 4 weeks before study inclusion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferric carboxymaltose	Supplementation of ferric carboxymaltose	Supplementation of ferric carboxymaltose 500 mg at week 0, 10, 20, 30
Iron sucrose	Supplementation of iron sucrose	Supplementation of iron sucrose 100 mg at week 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38

Primary Outcome Measures

Name	Time	Method
Serum hemoglobin level (g/dl)	40 weeks

Secondary Outcome Measures

Name	Time	Method
Serum ferritin level (µg/l)	Week 0, 10, 20, 30, 40
Serum transferrin level (mg/dl)	Week 0, 10, 20, 30, 40
Serum level of transferrin saturation (TSAT) (%)	Week 0, 10, 20, 30, 40
ESA consumption in I.E./week or µg/week as appropriate	Week 0, 10, 20, 30, 40

Trial Locations

Locations (2)

Medical University of Vienna, Division of Nephrology and Dialysis; 🇦🇹 Vienna, Austria

Wiener Dialysezentrum GmbH; 🇦🇹 Vienna, Austria