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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-05-31

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.

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Detailed Description

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Conditions

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Anemia of Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ferric carboxymaltose

Supplementation of ferric carboxymaltose 500 mg at week 0, 10, 20, 30

Group Type ACTIVE_COMPARATOR

Supplementation of ferric carboxymaltose

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Supplementation of iron sucrose

Intervention Type DRUG

Interventions

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Supplementation of ferric carboxymaltose

Intervention Type DRUG

Supplementation of iron sucrose

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No