Anemia of Chronic Kidney DiseasePhase 4COPEFERNCT02198495
Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients
A Phase 4 study testing Supplementation of ferric carboxymaltose and Supplementation of iron sucrose in people with Anemia of Chronic Kidney Disease, run by Medical University of Vienna at 2 sites in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia of Chronic Kidney Disease
- What is being tested?
- Supplementation of ferric carboxymaltose and Supplementation of iron sucrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 2 sitesAustria
- Study dates
- Sep 2014to May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medical University of Vienna, Division of Nephrology and Dialysis
Vienna, 1090
Wiener Dialysezentrum GmbH
Vienna, 1220
About this study
Official title: 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.
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- Supplementation of ferric carboxymaltose, Supplementation of iron sucrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation of ferric carboxymaltoseDrug
Supplementation of iron sucroseDrug
| Study group | Role | What they receive |
|---|---|---|
| Ferric carboxymaltose | Active comparator | Supplementation of ferric carboxymaltose 500 mg at week 0, 10, 20, 30 Receives: 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 Receives: Drug: Supplementation of iron sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum hemoglobin level (g/dl)
Measured: 40 weeks
Secondary outcomes (4)
Serum ferritin level (µg/l)
Measured: Week 0, 10, 20, 30, 40
Serum transferrin level (mg/dl)
Measured: Week 0, 10, 20, 30, 40
Serum level of transferrin saturation (TSAT) (%)
Measured: Week 0, 10, 20, 30, 40
ESA consumption in I.E./week or µg/week as appropriate
Measured: Week 0, 10, 20, 30, 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anemia of Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gere Sunder-Plassmann, Medical University of Vienna
- Investigators
- Gere Sunder-Plassmann, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198495
- Sponsor's protocol ID
- COPEFER
- Acronym
- COPEFER
- Status last verified
- Sep 2020
- First submitted
- 18 Jul 2014
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34470831
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Periodic Intravenous Iron Supplementation in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02198495
- Acronym / sponsor ID
- COPEFER / COPEFER
- Conditions
- Anemia of Chronic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric carboxymaltose | Active comparator | Drug: Supplementation of ferric carboxymaltoseSupplementation of ferric carboxymaltose 500 mg at week 0, 10, 20, 30 |
| Iron sucrose | Active comparator | Drug: Supplementation of iron sucroseSupplementation 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplementation of ferric carboxymaltose | Drug | Ferric carboxymaltose |
| Supplementation of iron sucrose | Drug | Iron sucrose |
Primary outcome
Serum hemoglobin level (g/dl)
Time frame: 40 weeks
4 secondary outcomes
Serum ferritin level (µg/l)
Time frame: Week 0, 10, 20, 30, 40
Serum transferrin level (mg/dl)
Time frame: Week 0, 10, 20, 30, 40
Serum level of transferrin saturation (TSAT) (%)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Derived from this study: PubMed 34470831Bielesz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gere Sunder-Plassmann, MD principal investigator
Medical University of Vienna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Supplementation of ferric carboxymaltose and Supplementation of iron sucrose in people with Anemia of Chronic Kidney Disease, run by Medical University of Vienna at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum hemoglobin level (g/dl) (time frame: 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02198495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.