Iron DeficiencyPhase 4NCT02232906
Switch From Oral Iron to Intravenous Ferric Carboxymaltose in Non-dialysis Chronic Kidney Disease (CKD)
A Phase 4 study testing intravenous ferric carboxymaltose in people with Iron Deficiency and Anaemia, run by Hospital Aleman at 1 site in Argentina.
Trial summary
Investigation whether a switch from oral iron to intravenous ferric carboxymaltose can reduce dose requirements of erythropoiesis-stimulating agents (ESA) and improve Hb levels and iron status in adult patients with non-dialysis-dependent CKD who were on a stable ESA/oral iron schedule for 6 months prior to enrolment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency, Anaemia
- What is being tested?
- intravenous ferric carboxymaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteArgentina
- Study dates
- Mar 2011to Sep 2013
- 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
- >18 years of age
- Creatinine clearance ≤40 mL/min
- Hemoglobin 110-120 g/L
- Serum ferritin <100 µg/L or transferrin saturation <20%
- Monthly treatment with ESA and oral iron for at least six months before enrolment
Who cannot join
- Other obvious cause of acute or chronic anemia than iron deficiency
- Expectation to require hemodialysis within the next six months
- Short life expectancy (<1 year)
- Pregnancy
- Decompensated heart failure
- History of allergic reactions to iron preparations and/or anaphylaxis from any cause
- Requirement of blood transfusions
- Chronic decompensated mental disorder or dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Open Label Study to Evaluate Intravenous Ferric Carboxymaltose (Ferinject ®) in Patients With CKD (Pre-dialysis) With Anemia Treated With Epo and Oral Iron in Buenos Aires, Argentina
Investigation whether a switch from oral iron to intravenous ferric carboxymaltose can reduce dose requirements of erythropoiesis-stimulating agents (ESA) and improve Hb levels and iron status in adult patients with non-dialysis-dependent CKD who were on a stable ESA/oral iron schedule for 6 months prior to enrolment.
- Conditions
- Iron Deficiency, Anaemia
- Being tested
- intravenous ferric carboxymaltose
- Keywords
- Chronic kidney disease, CKD, non-dialysis-dependent, ND-CKD, Erythropoiesis-stimulating agent, Ferric carboxymaltose, Iron
- Medical subject headings
- Iron Deficiencies, Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous ferric carboxymaltoseDrug
Also called Ferinject, Injectafer
Ferric carboxymaltose (FCM) dose of 1,000 mg iron, followed by a 6-month ESA/FCM maintenance regimen (target: Hemoglobin 120 g/L, transferrin saturation >20%)
| Study group | Role | What they receive |
|---|---|---|
| intravenous ferric carboxymaltose | Experimental | Not described Receives: Drug: intravenous ferric carboxymaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment
Measured: 6 months
Secondary outcomes (6)
Anaemia and iron status
Hemoglobin, mean corpuscular volume, serum ferritin and transferrin saturation were assessed at baseline and monthly until end of study
Measured: 6 months
Number of hospitalizations
Measured: 6 months
Number of transfusions
Measured: 6 months
Number of adverse reactions
Measured: 6 months
Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function
Measured: 6 months
Proteinuria at baseline and then bi-monthly until end of study as marker of renal function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startMar 2011
- Primary completionSep 2013
- Study completionSep 2013
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 Iron DeficiencyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Aleman
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Responsible party
- Principal investigator, Jorge Eduardo Toblli, Hospital Aleman
- Investigators
- Jorge E Toblli, Prof., MD, Principal investigator, Hospital Aleman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232906
- Sponsor's protocol ID
- FCM-ND-CKD 2012
- Status last verified
- Sep 2014
- First submitted
- 31 Aug 2014
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Toblli JE, Di Gennaro F. Switching patients with non-dialysis chronic kidney disease from oral iron to intravenous ferric carboxymaltose: effects on erythropoiesis-stimulating agent requirements, costs, hemoglobin and iron status. PLoS One. 2015 Apr 30;10(4):e0125528. doi: 10.1371/journal.pone.0125528. eCollection 2015.
PubMed 25928811
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Open Label Study to Evaluate Intravenous Ferric Carboxymaltose (Ferinject ®) in Patients With CKD (Pre-dialysis) With Anemia Treated With Epo and Oral Iron in Buenos Aires, Argentina
- ClinicalTrials.gov ID
- NCT02232906
- Acronym / sponsor ID
- FCM-ND-CKD 2012
- Conditions
- Iron Deficiency, Anaemia
- Keywords
- Chronic kidney disease, CKD, non-dialysis-dependent, ND-CKD, Erythropoiesis-stimulating agent, Ferric carboxymaltose, Iron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital AlemanUniversity, hospital or other
- Collaborators
- Vifor Pharma
- Study start
- Mar 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 Sep 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.
Investigation whether a switch from oral iron to intravenous ferric carboxymaltose can reduce dose requirements of erythropoiesis-stimulating agents (ESA) and improve Hb levels and iron status in adult patients with non-dialysis-dependent CKD who were on a stable ESA/oral iron schedule for 6 months prior to enrolment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intravenous ferric carboxymaltose | Experimental | Drug: intravenous ferric carboxymaltose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years of age
- Creatinine clearance ≤40 mL/min
- Hemoglobin 110-120 g/L
- Serum ferritin <100 µg/L or transferrin saturation <20%
- Monthly treatment with ESA and oral iron for at least six months before enrolment
Key exclusion criteria (8 listed)
- Other obvious cause of acute or chronic anemia than iron deficiency
- Expectation to require hemodialysis within the next six months
- Short life expectancy (<1 year)
- Pregnancy
- Decompensated heart failure
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 |
|---|---|---|
| intravenous ferric carboxymaltoseAlso: Ferinject, InjectaferFerric carboxymaltose (FCM) dose of 1,000 mg iron, followed by a 6-month ESA/FCM maintenance regimen (target: Hemoglobin 120 g/L, transferrin saturation >20%) | Drug | intravenous ferric carboxymaltose |
Primary outcome
ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment
Time frame: 6 months
6 secondary outcomes
Anaemia and iron status
Time frame: 6 months
Number of hospitalizations
Time frame: 6 months
Number of transfusions
Time frame: 6 months
Number of adverse reactions
Time frame: 6 months
Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function
Time frame: 6 months
Proteinuria at baseline and then bi-monthly until end of study as marker of renal function
Time frame: 6 months
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 5 Sep 2014.
- Derived from this study: PubMed 25928811Toblli JE, Di Gennaro F. Switching patients with non-dialysis chronic kidney disease from oral iron to intravenous ferric carboxymaltose: effects on erythropoiesis-stimulating agent requirements, costs, hemoglobin and iron status. PLoS One. 2015 Apr 30;10(4):e0125528. doi: 10.1371/journal.pone.0125528. eCollection 2015.
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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.
Jorge E Toblli, Prof., MD principal investigator
Hospital Aleman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravenous ferric carboxymaltose in people with Iron Deficiency and Anaemia, run by Hospital Aleman at 1 site in Argentina.
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 5 inclusion and 8 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 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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?
ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment (time frame: 6 months). 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 NCT02232906, 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 5 Sep 2014.