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

NCT02198495 | Completed Phase 4

• 1 other identifier: COPEFER
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 2

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.

Conditions

Anemia of Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Serum hemoglobin level (g/dl)

  40 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

Ferric carboxymaltose

ACTIVE COMPARATOR

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

Drug: Supplementation of ferric carboxymaltose

Iron sucrose

ACTIVE COMPARATOR

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

Interventions

Supplementation of ferric carboxymaltose DRUG

Ferric carboxymaltose

Supplementation of iron sucrose DRUG

Iron sucrose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Participation in a different study at the same time
• Active bleeding issues
• Mental diseases
• Bronchial asthma
• Atopic allergy
• Eczema

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (2)

Medical University of Vienna, Division of Nephrology and Dialysis

Vienna, 1090, Austria

Location

Wiener Dialysezentrum GmbH

Vienna, 1220, Austria

Location

Related Publications (1)

• Bielesz B, Lorenz M, Monteforte R, Prikoszovich T, Gabriel M, Wolzt M, Gleiss A, Horl WH, Sunder-Plassmann G. Comparison of Iron Dosing Strategies in Patients Undergoing Long-Term Hemodialysis: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2021 Oct;16(10):1512-1521. doi: 10.2215/CJN.03850321. Epub 2021 Sep 1.

  PMID: 34470831 DERIVED

Study Officials

• Gere Sunder-Plassmann, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 23, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 11, 2020

Record last verified: 2020-09

Locations

AU (2)