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

Primary Purpose

Anemia of Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Supplementation of ferric carboxymaltose
Supplementation of iron sucrose
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia of Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Vienna, Division of Nephrology and Dialysis
  • Wiener Dialysezentrum GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ferric carboxymaltose

Iron sucrose

Arm Description

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

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

Outcomes

Primary Outcome Measures

Serum hemoglobin level (g/dl)

Secondary Outcome Measures

Serum ferritin level (µg/l)
Serum transferrin level (mg/dl)
Serum level of transferrin saturation (TSAT) (%)
ESA consumption in I.E./week or µg/week as appropriate

Full Information

First Posted
July 18, 2014
Last Updated
September 10, 2020
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT02198495
Brief Title
Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients
Acronym
COPEFER
Official Title
Continuous Versus Periodic Intravenous Iron Supplementation in Maintenance Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferric carboxymaltose
Arm Type
Active Comparator
Arm Description
Supplementation of ferric carboxymaltose 500 mg at week 0, 10, 20, 30
Arm Title
Iron sucrose
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Supplementation of ferric carboxymaltose
Intervention Type
Drug
Intervention Name(s)
Supplementation of iron sucrose
Primary Outcome Measure Information:
Title
Serum hemoglobin level (g/dl)
Time Frame
40 weeks
Secondary Outcome Measure Information:
Title
Serum ferritin level (µg/l)
Time Frame
Week 0, 10, 20, 30, 40
Title
Serum transferrin level (mg/dl)
Time Frame
Week 0, 10, 20, 30, 40
Title
Serum level of transferrin saturation (TSAT) (%)
Time Frame
Week 0, 10, 20, 30, 40
Title
ESA consumption in I.E./week or µg/week as appropriate
Time Frame
Week 0, 10, 20, 30, 40

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gere Sunder-Plassmann, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Division of Nephrology and Dialysis
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Wiener Dialysezentrum GmbH
City
Vienna
ZIP/Postal Code
1220
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
34470831
Citation
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.
Results Reference
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Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients

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