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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01131624




Registration number
NCT01131624
Ethics application status
Date submitted
25/05/2010
Date registered
27/05/2010
Date last updated
29/05/2015

Titles & IDs
Public title
Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Women
Scientific title
An Open-label, Multicentre, Randomised, 2-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose Versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Pregnant Women
Secondary ID [1] 0 0
FER-ASAP-2009-01
Universal Trial Number (UTN)
Trial acronym
ASAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ferrous sulphate
Treatment: Drugs - Ferinject

Active Comparator: Ferric carboxymaltose - Subjects with bw =66 kg will receive an infusion of 1,000 mg iron as FCM and after 1 week a further 500 mg iron as FCM, depending on Hb at screening.
subjects with bw <66 kg, 2-3 infusions of 500 mg iron as FCM will be administered within 2 weeks from baseline, depending on Hb at screening

Active Comparator: Oral Iron - Oral Iron oral iron preparation will be provided at 200 mg iron per day in a convenient dosage schedule.


Treatment: Drugs: ferrous sulphate
200 mg iron per day in a convenient dosage schedule.

Treatment: Drugs: Ferinject
1000-1500mg diluted only in sterile 0.9% sodium chloride, The maximum single dose of FCM that can be administered by intravenous infusion is 20 mL (1,000 mg iron) but should not exceed 15 mg of iron per kg of body weight. This means that for subjects with a bw below 66 kg a maximal dose of 500 mg iron per infusion is allowed.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Average Hb increase after 3 weeks in FCM compared to oral iron treated subjects (superiority).
Timepoint [1] 0 0
3 weeks after baseline
Secondary outcome [1] 0 0
Change in Hb from baseline at Week 6
Timepoint [1] 0 0
6 weeks after baseline
Secondary outcome [2] 0 0
Change in Hb from baseline at Week 9
Timepoint [2] 0 0
9 weeks after baseline
Secondary outcome [3] 0 0
Change in Hb from baseline at Week 12
Timepoint [3] 0 0
12 weeks after baseline

Eligibility
Key inclusion criteria
- Pregnant women aged =18, gestational week =20, =33 at baseline visit with normal
antenatal screening test results.

- Iron deficiency anaemia defined as Hb concentration =8 g/dl and =10.4 g/dL and serum
ferritin =20 mcg/L at screening.

- Demonstrated the ability to understand the requirements of the study, abide by the
study restrictions, and agree to return for the required assessments. Patients (or
their representative) must provide written informed consent for their participation in
the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Blood transfusion, erythropoietin treatment, parenteral iron or oral iron treatment (1
month prior to screening) or anticipated need for a blood transfusion during the
study.

- Anaemia not caused by iron deficiency (e.g., aplastic, megaloblastic or haemolytic
anaemia) or related to acute or ongoing, haemoglobinopathies, rheumatic and other
chronic diseases, autoimmune diseases, malignancies, bone marrow diseases, enzyme
defects and drug induced anaemia.

- Acute or chronic infection, clinically relevant active inflammatory disease
(C-reactive protein >10 mg/dl or outside reference range), any acute infection at
screening.

- Pre-eclampsia.

- Multiple pregnancy.

- Evidence on any significant abnormalities on anomaly ultrasound.

- Haemochromatosis or other iron storage disorders.

- Folate deficiency (S-folate <4.5 nmol/L) at screening.

- Vitamin B12 deficiency (S-cobalamin <145 pmol/L) at screening.

- Serious medical condition, uncontrolled systemic disease or any other medical
condition that, in the judgment of the Investigator, prohibits the patient from
entering or potentially completing the study.

- Known chronic renal failure (defined as creatinine clearance <30 mL/min calculated by
Cockcroft-Gault or modification of diet in renal disease formula).

- Severe cardiovascular diseases.

- Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B
virus or hepatitis C virus infection.

- Inability to fully comprehend and/or perform study procedures in the Investigator's
opinion

- History of endocrine disorders

- Ongoing significant neurological or psychiatric disorders including psychotic
disorders or dementia

- Recent significant bleeding/surgery (within the 3 months prior to screening).

- Chronic/acute hepatic disorder or elevating of liver enzymes (aspartate
aminotransferase, alanine aminotransferase) over 2 times above the upper normal limit
at screening.

- Participation in any other interventional study since estimated conception and
throughout study participation.

- Known hypersensitivity to FCM or other IV iron preparations.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
252
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 0 0
3076 - Epping
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Berlin
Country [2] 0 0
Germany
State/province [2] 0 0
Marburg
Country [3] 0 0
Germany
State/province [3] 0 0
München
Country [4] 0 0
Sweden
State/province [4] 0 0
Falun
Country [5] 0 0
Sweden
State/province [5] 0 0
Lund
Country [6] 0 0
Sweden
State/province [6] 0 0
Stockholm
Country [7] 0 0
Sweden
State/province [7] 0 0
Uppsala
Country [8] 0 0
Switzerland
State/province [8] 0 0
Basel
Country [9] 0 0
Switzerland
State/province [9] 0 0
Bern
Country [10] 0 0
Switzerland
State/province [10] 0 0
Genève
Country [11] 0 0
Switzerland
State/province [11] 0 0
Lausanne
Country [12] 0 0
Switzerland
State/province [12] 0 0
Lugano
Country [13] 0 0
Switzerland
State/province [13] 0 0
Zürich
Country [14] 0 0
Turkey
State/province [14] 0 0
Adana
Country [15] 0 0
Turkey
State/province [15] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vifor Pharma
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Pierrel Research Europe GmbH
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to look at how well Ferric Carboxymaltose, an intravenous iron
therapy (iron that is infused directly into your body through a vein), compares with ferrous
sulphate capsules taken by mouth in the treatment of iron deficiency anaemia during
pregnancy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01131624
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christian Breymann
Address 0 0
University of Zurich
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01131624