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IV Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Iron Deficiency Anemia at Delivery in Tanzania (Ferinject)

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ClinicalTrials.gov Identifier: NCT02541708
Recruitment Status : Unknown
Verified April 2017 by Ifakara Health Institute.
Recruitment status was:  Active, not recruiting
First Posted : September 4, 2015
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Swiss Tropical & Public Health Institute
Information provided by (Responsible Party):
Ifakara Health Institute

Tracking Information
First Submitted Date  ICMJE August 12, 2015
First Posted Date  ICMJE September 4, 2015
Last Update Posted Date April 25, 2017
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2015)
Percentage of women with correction of hemoglobin to normal values (Hb> 11.5g/dl) at 6 weeks by treatment arm [ Time Frame: 6 weeks ]
The proportion of women in each trial arm who have attained the corrected hemoglobin to normal values after starting trial treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2015)
  • Best response (Hemoglobin) in grams per decilitre (g/dl) [ Time Frame: up to 1 year ]
    Is the highest hemoglobin value or maximal hemoglobin increase after start of study medication
  • Percentage of women with corrected iron deficiency (Ferritin>50ng/ml) in each arm [ Time Frame: 6 weeks ]
    The proportion of women in each trial arm who have attained the corrected serum ferritin levels to normal values after starting trial treatment in nanograms per milliltre(ng/mL)
  • Best response (Ferritin) in nanograms per milliltre (ng/mL) [ Time Frame: up to 1 year ]
    Is the highest ferritin value or maximal ferritin increase after start of study medication. The proportion of women in each trial arm who have attained the corrected serum ferritin levels to normal values after starting trial treatment
  • Time to response (Hemoglobin) in weeks [ Time Frame: up to 1 year ]
    Is the time interval between the date of start of study medication until the date of reaching maximal hemoglobin value
  • Time to response (Ferritin) in weeks [ Time Frame: up to 1 year ]
    Is the time interval between the date of start of study medication until the date of reaching maximal ferritin value
  • Response duration (Hemoglobin) in weeks [ Time Frame: up to 1 year ]
    Is the time from the date when the highest hemoglobin value is reached until the date of decrease to Hb<11.5 g/dl or a decrease of more than 1 g/dl
  • Response duration (Ferritin) in weeks [ Time Frame: up to 1 year ]
    Is the time from the date when the highest ferritin value is reached until the date of decrease to ferritin<50 ng/ml
  • Frequency and severity of solicited and non-solicited adverse events after IV ferric carboxymaltose substitution and oral iron substitution [ Time Frame: up to 1 year ]
    Number of participants with adverse events either clinical events or abnormal laboratory values with grading of severity reported according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4
  • Compliance to study medication intake after intravenous ferric carboxymaltose substitution and oral iron substitution (Questionnaire and pill count) [ Time Frame: up to 1 year ]
    The proportion of women in each trial arm who have completed the trial related treatment either the number of prescribed infusions of ferric carboxymaltose or oral tablets of ferrous sulphate and folic acid
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 2, 2015)
  • Sensitivity of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania (parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC) [ Time Frame: 1 year ]
    Is the probability that a test (erythrocyte indices) will indicate iron deficiency among participants with the disease as confirmed by iron metabolism parameters (Gold standard). It will be reported as percentage.
  • Specificity of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania ((parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC) [ Time Frame: 1 year ]
    Is the fraction of those without disease (iron deficiency) confirmed by iron metabolism parameters who will have a negative test (erythrocyte indices) results. It will be reported as percentage.
  • Positive predictive value of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania (parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC) [ Time Frame: 1 year ]
    Is the proportion of participants who truly have the disease(iron deficiency) as confirmed by iron metabolism parameters among the total number of participants with positive test results(erythrocyte indices). It will be reported as percentage.
  • Negative predictive value of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania (parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC) [ Time Frame: 1 year ]
    Is the proportion of participants who do not have the disease(iron deficiency) as confirmed by iron metabolism parameters among the total number of participants with negative test results(erythrocyte indices). It will be reported as percentage.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE IV Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Iron Deficiency Anemia at Delivery in Tanzania
Official Title  ICMJE Intravenous Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Iron Deficiency Anemia at Delivery in Tanzania
Brief Summary Intravenous iron preparations have been shown to be superior to oral iron and have largely replaced the treatment of anaemia in Northern countries. However, the socio-economic and medical conditions in low resource countries greatly differ from those in northern countries. Patients' different access to medication supply, perception of medication need and compliance as well as the burden of concomitant disease like malaria, soil-transmitted helminths, schistosomiasis, HIV and red blood cells (RBC) genetic disorders may influence effectiveness and safety of iron substitution modality. The aim of the present study is to compare iv iron substitution by ferric carboxymaltose (Ferinject®) to per oral iron substitution in a low resource country
Detailed Description

The objectives of the study are as follows:

Primary objective:

To assess the superiority in terms of effectiveness of iv iron substitution with ferric carboxymaltose versus per oral iron substitution in women with iron deficient anemia at delivery in Tanzania.

Secondary objectives

  • To evaluate safety and feasibility of intravenous ferric carboxymaltose substitution compared to per oral iron substitution in a resource limited country
  • To evaluate acceptance of intravenous ferric carboxymaltose substitution compared to per oral iron substitution in a resource limited country
  • To evaluate wellbeing of women receiving intravenous ferric carboxymaltose compared to women receiving per oral iron substitution
  • To evaluate the sensitivity of diagnosis of iron deficiency by measuring hemoglobin, mean corpuscular volume (MCV) and mean corpuscular hemoglobin concentration (MCHC) only, compared to the diagnosis by measuring iron metabolism parameters in a resource limited country
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Iron-Deficiency Anemia
Intervention  ICMJE
  • Drug: Ferric carboxymaltose
    Intravenous Ferric carboxymaltose given at a calculated dose of 20mg/kg body weight in 1-3 infusions according to severity of anemia
    Other Name: Ferinject
  • Drug: Ferrous sulfate + folic acid
    Three dried ferrous sulfate and folic acid tablets every morning 30 mins before the meal. If side effects occur the drug may be taken with the meal or in 2 separate doses per day. The treatment will be pursued for 3 months after correction of anemia
    Other Name: Fefo
Study Arms  ICMJE
  • Experimental: IV ferric carboxymaltose
    IV Ferric carboxymaltose is given at a dose calculated according to the severity of anemia and patients weight. The maximal weekly dose is 1000mg. If total dose exceeds 1000mg the dose is split in 1-3 infusions with one infusion per week.
    Intervention: Drug: Ferric carboxymaltose
  • Active Comparator: Ferrous sulphate 60mg+Folic acid 0.25mg
    Three dried ferrous sulphate and folic acid tablets every morning 30 mins before the meal. If side effects occur the drug may be taken with the meal or in 2 separate doses per day. The treatment will be pursued for 3 months after correction of anemia.
    Intervention: Drug: Ferrous sulfate + folic acid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 2, 2015)
230
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2018
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women close to delivery
  • Screening will be performed using the HemoCue System. In case of anemia, defined by Hg <110 g/l, a venous puncture will be performed and the blood analyzed on a 5 population analyzer with erythrocyte indices and Reticulocyte indices and ferritin determined. Then If the anemia defined as Hg <110 g/l is confirmed and the if ferritin is below 50 ng/ml, the patient will be included in the present study
  • Patient compliance and geographic proximity allow proper staging and follow-up
  • Patient must give written informed consent before registration

Exclusion Criteria:

  • Active malaria; patients will be tested for malaria by Rapid Diagnostic Test and microscopy and if positive treated. Patient with treated malaria can be included
  • Helminthic infection; patients will be tested for helminthic infections by a stool ova and parasite exam and if positive treated by single oral dose of 400 mg albendazole. Treated patients can be included.
  • HIV positivity. Patients will be tested and if positive they will be referred to the Care and Treatment Clinic at Bagamoyo District Hospital and excluded from the study.
  • Known hemoglobinopathy
  • C-Reactive protein (CRP) >20
  • Patients with chronic fever
  • Psychiatric disorder precluding understanding of information on trial related topics or giving informed consent
  • Concurrent treatment with other experimental drugs or treatment in another clinical trial within 30 days prior to trial entry
  • Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial
  • Known allergy or hypersensitivity to study drug.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02541708
Other Study ID Numbers  ICMJE IFCIDA 001-2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ifakara Health Institute
Study Sponsor  ICMJE Ifakara Health Institute
Collaborators  ICMJE Swiss Tropical & Public Health Institute
Investigators  ICMJE
Principal Investigator: Sandrine Meyer-Monard, PD DrMed Swiss Tropical & Public Health Institute
Study Chair: Salim Abdulla, MD,PhD Ifakara Health Institute
Study Chair: Marcel Tanner, PhD, MPH Swiss Tropical & Public Health Institute
PRS Account Ifakara Health Institute
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP