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Iron Deficiency AnemiaPhase 4ACCESSNCT03524651

Ferrous Acetyl-Aspartate Casein Formulation Evaluation Over Ferrous Sulfate in Iron Deficiency Anemia

A Phase 4 study testing Ferrous Sulfate and Fe-ASP in people with Iron Deficiency Anemia, run by Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. at 3 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The scope of this study is to compare the efficacy of the new oral formulation of Fe-ASP to oral ferrous sulfate in patients with iron deficiency anemia (IDA) for the restoration of decreased circulating Hb. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Iron Deficiency Anemia
What is being tested?
Ferrous Sulfate and Fe-ASP
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesGreece
Study dates
2 May 2018to 8 Jan 2021
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

  • Male or female
  • Age equal to or more than 18 years
  • Written informed consent provided by the patient
  • Hb below 10g/dl, as defined by other trials
  • Absolute red blood cell (RBC) count below 4.5 x 106/mm3 for men or 4.0 x 106/mm3 for women
  • Mean corpuscular volume (MCV) of RBCs below 80 fl
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  • Mean corpuscular Hb (MCH) of RBCs below 27 pg
  • Total ferritin below 30 ng/ml; this criterion is associated with sensitivity more than 99% for iron deficiency
  • In the case of patients with anemia after GI tract hemorrhage, inclusion criteria 6 and 7 DO NOT apply for study inclusion.

Who cannot join

  • Age below 18 years
  • Denial to provide written informed consent
  • Acute myelogenous or lymphoblastic leukemia
  • Multiple myeloma
  • Primary or secondary myelodysplastic syndrome
  • Planning for start of chemotherapy within the first 30 days after inclusion in the trial
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  • Planning for start of radiotherapy within the first 30 days after inclusion in the trial
  • Intake of erythropoietin
  • Planning for start of erythropoietin within the first 30 days after inclusion in the trial
  • Intake of chemotherapy the last six months
  • Intake of radiotherapy the last six months
  • Known hemochromatosis
  • Known celiac disease
  • Liver cirrhosis of Child-Pugh stage II or III
  • Any active overt bleeding
  • Pregnancy or lactation

Trial locations and contacts

3 sites in 1 country.

Greece3 sites

  • General Hospital of Athens G. Gennimatas

    Athens, 115 27

  • Attikon University Hospital

    Haidari/Athens, 12462

  • Amalia Fleming Prefecture General Hospital of Melissia

    Melíssia, 15127

Other trials in Greece

About this study

Official title: Ferrous Acetyl-Aspartate Casein Formulation Evaluation Over Ferrous Sulfate in Iron Deficiency Anemia (ACCESS): A Double-Dummy Randomized Clinical Trial

The scope of this study is to compare the efficacy of the new oral formulation of Fe-ASP to oral ferrous sulfate in patients with iron deficiency anemia (IDA) for the restoration of decreased circulating Hb. The improvement of symptoms of anemia, the restoration of biomarkers of iron deficiency into the normal range and the incidence of GI tract side effects are the study secondary endpoints.

Read the detailed description

Anemia is a major problem in the general population affecting 5.6% in the United States. Iron deficiency is the most common cause of anemia. Although traditionally considered to be mainly a problem of underdeveloped countries, a recent epidemiological survey reported high incidence of iron deficiency anemia (IDA) in Europe in 2011. The incidence rate measured per 1,000 person-years was 8.18 in Belgium, 8.93 in Italy, 12.42 in Germany and 14.14 in Spain. Women were affected four-times more than men. The major causes of IDA are chronic blood loss, chronic disorders and excess needs.

The cornerstones of management of IDA are recognition and management of the cause of iron loss and efficient iron supplementation. Iron supplementation is usually done through oral formulations of iron. Three oral iron preparations are broadly used: ferrous sulfate, ferrous gluconate, and ferrous fumarate. The usual dosage is 325 mg (corresponding to 65 mg of elemental iron) two times a day. One major limitation with oral iron supplementation is GI side effects observed in almost 40% of cases. These are gastric discomfort, nausea, vomiting and constipation and they are caused due to the oxidation of ferrous irons in the stomach by acidic gastric fluid into insoluble salts.

A new formulation of iron conjugated to one N-acetyl-aspartate derivative of casein (Fe-ASP) has recently been developed. Due to the casein coating, it is anticipated that iron is converted to a smaller extent in the stomach into insoluble salts. In this way, more iron reaches the duodenum to become absorbed whereas GI side effects are less often. In parallel, animal studies have shown that casein itself primes the expression of enzymes that facilitate the absorption of iron across the duodenal mucosa.

This formulation is anticipated to be better tolerated for oral ingestion since iron is readily absorbed in the duodenum. The aim is to compare the efficacy of the new oral formulation of Fe-ASP to oral ferrous sulfate in patients with IDA for the restoration of decreased circulating Hb.

Being tested
Ferrous Sulfate, Fe-ASP
Keywords
Iron Deficiency Anemia, Fe-ASP, Casein, Iron protein acetyl aspartate, Restoration of decreased hemoglobin, Ferrous sulfate
Medical subject headings
Anemia, Iron-Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferrous SulfateDrug

    Also called Microfer

    Blisters of 10 capsules containing 150 mg of ferrous sulfate.

  • Fe-ASPDrug

    Also called Omalin

    Boxes of 10 vials of 15 ml containing 800 mg of Iron protein acetyl aspartate.

  • Ferrous SulfateDrug

    Also called Omalin placebo

    Boxes of 10 vials of 15 ml containing inactive ingredients of Omalin.

  • Fe-ASPDrug

    Also called Microfer placebo

    Blisters of 10 capsules containing inactive ingredients of Microfer.

Study groups in NCT03524651
Study groupRoleWhat they receive
Ferrous sulfateActive comparatorPatients will take every day for 12 weeks two oral capsules of 150 mg ferrous sulfate delivering 47 mg of active elemental iron. Capsules should be taken orally either two hours before meal or two hours after meal. The same patients will take every day on exactly the same time for 12 weeks two placebo vials of 15 ml volume with excipients contained in the commercially available formulation Fe-Asp Omalin (Uni-Pharma SA).
Receives: Drug: Ferrous Sulfate
Fe-ASPActive comparatorPatients will take every day for 12 weeks two oral placebo capsules. Capsules should be taken orally either two hours before meal or two hours after meal. The same patients will take every day on exactly the same time for 12 weeks two vials of 15 ml volume of the Fe-Asp preparation Omalin (Uni-Pharma SA) delivering 40 mg of elemental iron.
Receives: Drug: Fe-ASP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparative increase of baseline Hb

    The primary study endpoint is the comparative increase of baseline Hb in each study group after the first 4 weeks of treatment. Since the daily amount of elemental iron delivered with the ferrous sulfate regimen is 94 mg and with the Fe-ASP regimen 80 mg, the increase of baseline Hb will be adjusted per mg of delivered elemental iron.

    Measured: 4 weeks

Secondary outcomes (7)

  1. Normalization of Hb

    Differences between the two groups of treatment in normalization of Hb; this is defined as Hb≥13 g/dl for mean and ≥12 g/dl for women.

    Measured: 4 weeks and 12 weeks

  2. Ferritin levels

    Differences between the two groups of treatment in ferritin levels.

    Measured: 4 weeks and 12 weeks

  3. Absolute reticulocyte count

    Differences between the two groups of treatment in absolute reticulocyte count.

    Measured: 1 week, 4 weeks and 12 weeks

  4. Absolute RBC count, Hb, MCV and MCH

    Differences between the two groups of treatment in absolute RBC count, Hb, MCV and MCH.

    Measured: 4 weeks and 12 weeks

  5. Fatigue symptoms of IDA

    Differences between the two groups of treatment in change of the fatigue symptoms of IDA.

    Measured: 4 weeks and 12 weeks

  6. Physical findings of IDA

    Differences between the two groups of treatment in change of physical findings of IDA.

    Measured: 4 weeks and 12 weeks

  7. Incidence of GI side effects

    Differences between the two groups of treatment in the incidence of GI side effects.

    Measured: 4 weeks and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2018
  2. Study start2 May 2018
  3. Primary completion8 Jan 2021
  4. Study completion8 Jan 2021

Resources

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
Model description
Double-dummy, blind, randomized, phase IV clinical trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03524651
Sponsor's protocol ID
Omalin-01/ACCESS
Acronym
ACCESS
Status last verified
Apr 2021
First submitted
2 May 2018
Last updated
9 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lazzari F, Carrara M. Overview of clinical trials in the treatment of iron deficiency with iron-acetyl-aspartylated casein. Clin Drug Investig. 2005;25(11):679-89. doi: 10.2165/00044011-200525110-00001.

    PubMed 17532714

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ferrous Sulfate and Fe-ASP in people with Iron Deficiency Anemia, run by Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. at 3 sites in Greece.

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 9 inclusion and 16 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 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Greece. 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?

Comparative increase of baseline Hb (time frame: 4 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 NCT03524651, 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 9 Apr 2021.

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