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

Study Overview
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Brief Summary
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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.

Official Title
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Continuous Versus Periodic Intravenous Iron Supplementation in Maintenance Hemodialysis Patients

Conditions
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Anemia of Chronic Kidney Disease

Intervention / Treatment
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* Drug: Supplementation of ferric carboxymaltose
* Drug: Supplementation of iron sucrose


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ferric carboxymaltose<br>Supplementation of ferric carboxymaltose 500 mg at week 0, 10, 20, 30 | Drug: Supplementation of ferric carboxymaltose<br> <br> |
| Active Comparator: Iron sucrose<br>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 | Drug: Supplementation of iron sucrose<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum hemoglobin level (g/dl) |  | 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |