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

NCT02541708 | Unknown Phase 3 DMC

• 1 other identifier: IFCIDA 001-2015
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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

Conditions

Iron-Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Percentage of women with correction of hemoglobin to normal values (Hb> 11.5g/dl) at 6 weeks by treatment arm

  The proportion of women in each trial arm who have attained the corrected hemoglobin to normal values after starting trial treatment.

  6 weeks

Secondary Outcomes (9)

• Best response (Hemoglobin) in grams per decilitre (g/dl)

  up to 1 year

• Percentage of women with corrected iron deficiency (Ferritin>50ng/ml) in each arm

  6 weeks

• Best response (Ferritin) in nanograms per milliltre (ng/mL)

  up to 1 year

• Time to response (Hemoglobin) in weeks

  up to 1 year

• Time to response (Ferritin) in weeks

  up to 1 year

Other Outcomes (4)

• 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)

  1 year

• 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)

  1 year

• 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)

  1 year

Study Arms (2)

IV ferric carboxymaltose

EXPERIMENTAL

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.

Drug: Ferric carboxymaltose

Ferrous sulphate 60mg+Folic acid 0.25mg

ACTIVE COMPARATOR

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.

Drug: Ferrous sulfate + folic acid

Interventions

Ferric carboxymaltose DRUG

Intravenous Ferric carboxymaltose given at a calculated dose of 20mg/kg body weight in 1-3 infusions according to severity of anemia

Also known as: Ferinject

IV ferric carboxymaltose

Ferrous sulfate + folic acid DRUG

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

Also known as: Fefo

Ferrous sulphate 60mg+Folic acid 0.25mg

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ifakara Health Institute: lead
• Swiss Tropical & Public Health Institute: collaborator

Study Sites (1)

Ifakara Health Institute

Bagamoyo, 74, Tanzania

Location

Related Publications (11)

• van Hensbroek MB, Jonker F, Bates I. Severe acquired anaemia in Africa: new concepts. Br J Haematol. 2011 Sep;154(6):690-5. doi: 10.1111/j.1365-2141.2011.08761.x. Epub 2011 Jun 28.

  PMID: 21707575 BACKGROUND

• Balarajan Y, Ramakrishnan U, Ozaltin E, Shankar AH, Subramanian SV. Anaemia in low-income and middle-income countries. Lancet. 2011 Dec 17;378(9809):2123-35. doi: 10.1016/S0140-6736(10)62304-5. Epub 2011 Aug 1.

  PMID: 21813172 BACKGROUND

• Bodnar LM, Scanlon KS, Freedman DS, Siega-Riz AM, Cogswell ME. High prevalence of postpartum anemia among low-income women in the United States. Am J Obstet Gynecol. 2001 Aug;185(2):438-43. doi: 10.1067/mob.2001.115996.

  PMID: 11518906 BACKGROUND

• Zimmermann MB, Chassard C, Rohner F, N'goran EK, Nindjin C, Dostal A, Utzinger J, Ghattas H, Lacroix C, Hurrell RF. The effects of iron fortification on the gut microbiota in African children: a randomized controlled trial in Cote d'Ivoire. Am J Clin Nutr. 2010 Dec;92(6):1406-15. doi: 10.3945/ajcn.110.004564. Epub 2010 Oct 20.

  PMID: 20962160 BACKGROUND

• Lynch SR. Why nutritional iron deficiency persists as a worldwide problem. J Nutr. 2011 Apr 1;141(4):763S-768S. doi: 10.3945/jn.110.130609. Epub 2011 Mar 2.

  PMID: 21367937 BACKGROUND

• Van Wyck DB, Martens MG, Seid MH, Baker JB, Mangione A. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):267-78. doi: 10.1097/01.AOG.0000275286.03283.18.

  PMID: 17666600 BACKGROUND

• Van Wyck DB, Mangione A, Morrison J, Hadley PE, Jehle JA, Goodnough LT. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion. 2009 Dec;49(12):2719-28. doi: 10.1111/j.1537-2995.2009.02327.x. Epub 2009 Jul 22.

  PMID: 19682342 BACKGROUND

• Moore RA, Gaskell H, Rose P, Allan J. Meta-analysis of efficacy and safety of intravenous ferric carboxymaltose (Ferinject) from clinical trial reports and published trial data. BMC Blood Disord. 2011 Sep 24;11:4. doi: 10.1186/1471-2326-11-4.

  PMID: 21942989 BACKGROUND

• Rohner F, Zimmermann MB, Amon RJ, Vounatsou P, Tschannen AB, N'goran EK, Nindjin C, Cacou MC, Te-Bonle MD, Aka H, Sess DE, Utzinger J, Hurrell RF. In a randomized controlled trial of iron fortification, anthelmintic treatment, and intermittent preventive treatment of malaria for anemia control in Ivorian children, only anthelmintic treatment shows modest benefit. J Nutr. 2010 Mar;140(3):635-41. doi: 10.3945/jn.109.114256. Epub 2010 Jan 27.

  PMID: 20107144 BACKGROUND

• Beard JL, Hendricks MK, Perez EM, Murray-Kolb LE, Berg A, Vernon-Feagans L, Irlam J, Isaacs W, Sive A, Tomlinson M. Maternal iron deficiency anemia affects postpartum emotions and cognition. J Nutr. 2005 Feb;135(2):267-72. doi: 10.1093/jn/135.2.267.

  PMID: 15671224 BACKGROUND

• Vanobberghen F, Lweno O, Kuemmerle A, Mwebi KD, Asilia P, Issa A, Simon B, Mswata S, Schmidlin S, Glass TR, Abdulla S, Daubenberger C, Tanner M, Meyer-Monard S. Efficacy and safety of intravenous ferric carboxymaltose compared with oral iron for the treatment of iron deficiency anaemia in women after childbirth in Tanzania: a parallel-group, open-label, randomised controlled phase 3 trial. Lancet Glob Health. 2021 Feb;9(2):e189-e198. doi: 10.1016/S2214-109X(20)30448-4. Epub 2020 Nov 24.

  PMID: 33245866 DERIVED

Related Links

• Tanzania Food and Drugs Authority
• Swiss Tropical and Public Health Institute
• Ifakara Health Institute
• National Institute for Medical Research

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; ferrous sulfate; Folic Acid

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sandrine Meyer-Monard, PD DrMed

  Swiss Tropical & Public Health Institute

  PRINCIPAL INVESTIGATOR

• Salim Abdulla, MD,PhD

  Ifakara Health Institute

  STUDY CHAIR

• Marcel Tanner, PhD, MPH

  Swiss Tropical & Public Health Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: September 4, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

TA (1)