Iron Deficiency AnemiaPhase 4NCT01864161
Endovenous Versus Liposomal Iron in CKD
A Phase 4 study testing gluconate iron and Liposomal iron in people with Iron Deficiency Anemia and Chronic Kidney Disease, run by Federico II University at 1 site in Italy.
Trial summary
Anemia is a common complication in patients with chronic kidney disease (CKD). In addition to erythropoietin deficiency, many studies have identified iron deficiency as a cause of anemia in CKD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia, Chronic Kidney Disease
- What is being tested?
- gluconate iron and Liposomal iron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2011to May 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
- Age ≥ 18 years;
- Signed written informed consent;
- Glomerular filtration rate (GFR) ≤ 60 mL/min (MDRD GFR calculated according to 4 variables);
- hemoglobin ≤ 12g/dL;
- Ferritin ≤ 100ng/mL with transferrin saturation (TSAT) ≤ 25%;
- If erythropoiesis stimulating agents (ESA) therapy, stable dose for at least three months;
Who cannot join
- Infectious diseases;
- bleeding in the preceding six months;
- History of malignancy tumor in the last 3 years;
- Anemia case different from that resulting from CKD;
- vitamin B12 and folate deficiency;
- Surgery of any kind in the last three months;
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- systemic haematological disease;
- Blood Transfusions, therapy with intravenous or oral iron in the last three months;
- Severe liver disease / test positive for hepatitis C virus (HCV) and hepatitis B virus (HBV);
- Abuse of alcohol and drugs in the preceding six months;
- immunosuppressive therapy ;
- Significant weight loss;
- Pregnancy or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Anemia is a common complication in patients with chronic kidney disease (CKD). In addition to erythropoietin deficiency, many studies have identified iron deficiency as a cause of anemia in CKD patients. Most patients with CKD are iron deficient because of: inadequate intake and absorption, gastroenteric bleeding, urinary iron loss in patient with significant proteinuria. The iron treatment is pivotal to manage anemic patients with CKD: the prescription of iron is usually oral because of practicality and safety, but often it is inevitable to administer intravenous iron because of gastroenteric malabsorption, intolerance to oral administration, irregular intake. There're few randomized controlled studies about the efficacy of oral iron versus intravenous iron in patients not on dialysis; most of them demonstrate superiority of intravenous therapy to restore iron deficiency and hemoglobin levels. A particular formulation of iron, liposomal iron has a high gastroenteric absorption and high bioavailability with lower incidence of side effects. The investigators study aims to evaluate the efficacy of treatment with liposomal oral iron compared to intravenous iron in CKD anemic patients not on dialysis in the presence of iron deficiency.
- Conditions
- Iron Deficiency Anemia, Chronic Kidney Disease
- Being tested
- gluconate iron, Liposomal iron
- Medical subject headings
- Anemia, Iron-Deficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gluconate ironDrug
Also called FERLIXIT
FERLIXIT fl 15mg/kg divided into weekly administrations of 125mg up to a maximum of 1000mg
Liposomal ironDrug
Also called Sideral forte
Sideral forte 30 mg/die
| Study group | Role | What they receive |
|---|---|---|
| oral liposomal iron | Experimental | patients receive a dose of liposomal 30 mg/die iron (equivalent to 1 cp Sideral forte). Receives: Drug: Liposomal iron |
| endovenous iron | Active comparator | patients receive a total dose 1000 mg of intravenous iron gluconate divided into administrations of 125 mg diluted in 250 mL normal saline infused weekly for 3 months Receives: Drug: gluconate iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
modification in hemoglobin levels
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startOct 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Riccio, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864161
- Sponsor's protocol ID
- BIANCA79
- Status last verified
- Jan 2013
- First submitted
- 24 May 2013
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovenous Versus Liposomal Iron in CKD
- ClinicalTrials.gov ID
- NCT01864161
- Acronym / sponsor ID
- BIANCA79
- Conditions
- Iron Deficiency Anemia, Chronic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 29 May 2013 (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.
Anemia is a common complication in patients with chronic kidney disease (CKD). In addition to erythropoietin deficiency, many studies have identified iron deficiency as a cause of anemia in CKD patients. Most patients with CKD are iron deficient because of: inadequate intake and absorption, gastroenteric bleeding, urinary iron loss in patient with significant proteinuria. The iron treatment is pivotal to manage anemic patients with CKD: the prescription of iron is usually oral because of practicality and safety, but often it is inevitable to administer intravenous iron because of gastroenteric malabsorption, intolerance to oral administration, irregular intake. There're few randomized controlled studies about the efficacy of oral iron versus intravenous iron in patients not on dialysis; most of them demonstrate superiority of intravenous therapy to restore iron deficiency and hemoglobin levels. A particular formulation of iron, liposomal iron has a high gastroenteric absorption and high bioavailability with lower incidence of side effects. The investigators study aims to evaluate the efficacy of treatment with liposomal oral iron compared to intravenous iron in CKD anemic patients not on dialysis in the presence of iron deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral liposomal iron | Experimental | Drug: Liposomal ironpatients receive a dose of liposomal 30 mg/die iron (equivalent to 1 cp Sideral forte). |
| endovenous iron | Active comparator | Drug: gluconate ironpatients receive a total dose 1000 mg of intravenous iron gluconate divided into administrations of 125 mg diluted in 250 mL normal saline infused weekly for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years;
- Signed written informed consent;
- Glomerular filtration rate (GFR) ≤ 60 mL/min (MDRD GFR calculated according to 4 variables);
- hemoglobin ≤ 12g/dL;
- Ferritin ≤ 100ng/mL with transferrin saturation (TSAT) ≤ 25%;
Key exclusion criteria (13 listed)
- Infectious diseases;
- bleeding in the preceding six months;
- History of malignancy tumor in the last 3 years;
- Anemia case different from that resulting from CKD;
- vitamin B12 and folate deficiency;
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 |
|---|---|---|
| gluconate ironAlso: FERLIXITFERLIXIT fl 15mg/kg divided into weekly administrations of 125mg up to a maximum of 1000mg | Drug | endovenous iron |
| Liposomal ironAlso: Sideral forteSideral forte 30 mg/die | Drug | oral liposomal iron |
Primary outcome
modification in hemoglobin levels
Time frame: 3 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 24 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 gluconate iron and Liposomal iron in people with Iron Deficiency Anemia and Chronic Kidney Disease, run by Federico II University at 1 site in Italy.
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 6 inclusion and 13 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 24 Jul 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 Italy. 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?
modification in hemoglobin levels (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2014.