Ferric Carboxymaltose Treatment to Improve Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age

NCT01110356 | Completed Phase 4

• 1 other identifier: IDNA 2009-01
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

research study of Ferric carboxymaltose to treat fatigue/exhaustion symptoms, believed to be due to iron deficiency.

Conditions

Iron Deficiency

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of a single intravenous (IV) administration of FCM (1,000 mg) compared with placebo in improving fatigue symptoms in IDNA women of child bearing age.

  Day 56

Secondary Outcomes (2)

• To compare efficacy of a single IV application of FCM with that of placebo on change of iron status on Day 56 (i.e., proportion of subjects with haemoglobin (Hb) ≥12 g/dL; serum-ferritin (s-ferritin) ≥50 ng/mL; transferrin saturation (TfS) >20%).

  Day 56

• To determine the relationship between change in iron status (s-ferritin and TfS) and improvement of fatigue symptoms.

  Day 56

Study Arms (2)

Ferinject

EXPERIMENTAL

Drug: Ferinject

Saline

PLACEBO COMPARATOR

Other: Saline

Interventions

Ferinject DRUG

Ferric carboxymaltose will be provided in 2 vials of 10 mL containing each 500 mg iron, which will be diluted in 250 mL normal saline for injection. Study drug will be administered by drip infusion immediately after preparation over a minimum of 15 minutes. Placebo patients will be administered 250 mL normal saline for injection over a minimum of 15 minutes.

Ferinject

Saline OTHER

Placebo patients will be administered 250 mL normal saline for intravenous drip over a minimum of 15 minutes.

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to study specific procedures.
• Premenopausal, regularly menstruating women.
• Age ≥18 years.
• Body weight between 50 and 90 kg.
• Haemoglobin ≥115 g/L.
• Iron deficiency at screening defined as follows:
• S-ferritin level \<50 ng/mL, AND, TfS \<20%, OR,
• S-ferritin level \<15 ng/mL.
• Serum C-reactive protein:
• \<5 mg/L if not on oral contraception, OR,
• \<20 mg/L if use of oral contraception.
• Minimum total score of 5 on the Piper Fatigue Scale (PFS) (mean of items 2 to 23).
• Negative pregnancy test (serum human chorionic gonadotropin (hCG) at screening.
• Normal levels of vitamin B12 and folic acid at screening.
• Adequate contraception during the study period and for 1 month following study completion.

You may not qualify if:

• Haemoglobin level \<115 g/L.
• Haemoglobinopathy.
• Haemochromatose.
• Major depressive disorder based on Patient Health Questionnaire (PHQ-9) (5 items with scores ≥2; one of which corresponds to question number 1 or 2).
• Any active or unstable concurrent medical condition (e.g., cancer, renal dysfunction, liver dysfunction (aspartate aminotransferase (AST); alanine aminotransferase (ALT) \>3-fold upper limit), angina (Class IV).
• Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection.
• Chronic inflammatory disease (e.g., rheumatoid arthritis; inflammatory bowel disease).
• Documented history of clinically significant level of sleep apnoea defined as 5 or more episodes per hour of any type of apnoea.
• Intake of concurrent medications that could interfere with physical or mental performance (e.g., antidepressive, antihistamines, narcotic or any chemotherapeutic agents known to cause drowsiness).
• Important recent weight loss (\>10% within the past month).
• Body weight \<50 kg or \>90 kg.
• Thyroid dysfunction, thyroid stimulating hormone \>4 μU/mL.
• Intake of iron preparations 4 weeks prior to screening.
• Use of gestagens e.g., Implanon, Mirena, Depo-Provera for menstruation repression (see Section 7.7, Prohibited Therapy or Concomitant Treatment, page 35).
• Known hypersensitivity to FCM or to any other iron preparation.

Sponsors & Collaborators

• Vifor Pharma: lead
• SGS S.A.: collaborator

Study Sites (1)

Universitätsklinik für Frauenheilkunde

Vienna, 1090, Austria

Location

Related Publications (1)

• Favrat B, Balck K, Breymann C, Hedenus M, Keller T, Mezzacasa A, Gasche C. Evaluation of a single dose of ferric carboxymaltose in fatigued, iron-deficient women--PREFER a randomized, placebo-controlled study. PLoS One. 2014 Apr 21;9(4):e94217. doi: 10.1371/journal.pone.0094217. eCollection 2014.

  PMID: 24751822 DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferric carboxymaltose; Sodium Chloride

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Bernard Favrat

  Quartier UNIL-CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 26, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2012
• Last Updated: November 15, 2012

Record last verified: 2012-11

Locations

AU (1)