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

September 10, 2020 updated by: Gere Sunder-Plassmann, Medical University of Vienna

Continuous Versus Periodic Intravenous Iron Supplementation in Maintenance 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna, Division of Nephrology and Dialysis
      • Vienna, Austria, 1220
        • Wiener Dialysezentrum GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ferric carboxymaltose
Supplementation of ferric carboxymaltose 500 mg at week 0, 10, 20, 30
Drug: Supplementation of ferric carboxymaltose
ACTIVE_COMPARATOR: 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
Drug: Supplementation of iron sucrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum hemoglobin level (g/dl)
Time Frame: 40 weeks
40 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum ferritin level (µg/l)
Time Frame: Week 0, 10, 20, 30, 40
Week 0, 10, 20, 30, 40
Serum transferrin level (mg/dl)
Time Frame: Week 0, 10, 20, 30, 40
Week 0, 10, 20, 30, 40
Serum level of transferrin saturation (TSAT) (%)
Time Frame: Week 0, 10, 20, 30, 40
Week 0, 10, 20, 30, 40
ESA consumption in I.E./week or µg/week as appropriate
Time Frame: Week 0, 10, 20, 30, 40
Week 0, 10, 20, 30, 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2014

Primary Completion (ACTUAL)

May 1, 2019

Study Completion (ACTUAL)

May 1, 2019

Study Registration Dates

First Submitted

July 18, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (ESTIMATE)

July 23, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COPEFER

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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