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NCT Number: NCT02198495

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

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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Key information

Conditions

Anemia of Chronic Kidney Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna, Division of Nephrology and Dialysis, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supplementation of ferric carboxymaltose

Drug

Supplementation of iron sucrose

Drug

Primary outcomes

  1. Serum hemoglobin level (g/dl)

    Time frame: 40 weeks

Secondary outcomes

  1. Serum ferritin level (µg/l)

    Time frame: Week 0, 10, 20, 30, 40

  2. Serum transferrin level (mg/dl)

    Time frame: Week 0, 10, 20, 30, 40

  3. Serum level of transferrin saturation (TSAT) (%)

    Time frame: Week 0, 10, 20, 30, 40

  4. ESA consumption in I.E./week or µg/week as appropriate

    Time frame: Week 0, 10, 20, 30, 40

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Continuous Versus Periodic Intravenous Iron Supplementation in Maintenance Hemodialysis Patients

Acronym: COPEFER

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2014
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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