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

A Multicentre Randomised Placebo-controlled Study to Assess the Efficacy and Safety of a Single Administration of Ferric Carboxymaltose in Improving Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age

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

Study Overview

• Status: Completed
• Conditions: Iron Deficiency
• Intervention / Treatment: Drug: Ferinject; Other: Saline

• Study Type: Interventional
• Enrollment (Actual): 294
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Universitätsklinik für Frauenheilkunde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.
• Availability and willingness to complete all study visits and procedures per protocol.

Exclusion Criteria:

• 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.
• Pregnancy (positive hCG test at screening) or breast feeding.
• Participation in any other interventional trial within 4 weeks prior to screening.
• Inability to fully comprehend and/or perform study procedures or provide written consent in the Investigator's opinion.
• Subject is not using adequate contraceptive precautions during the study and for up to 1 month after the last dose of the study medication. A highly effective method of birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner.
• Subject previously has entered this study.
• Subject will not be available for follow-up assessments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Saline	Other: Saline; Placebo patients will be administered 250 mL normal saline for intravenous drip over a minimum of 15 minutes.
EXPERIMENTAL: Ferinject	Drug: Ferinject; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Vifor Pharma
• Collaborators: SGS S.A.
• Investigators: Principal Investigator: Bernard Favrat, Quartier UNIL-CHUV

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: April 22, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (ESTIMATE): April 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 15, 2012
• Last Update Submitted That Met QC Criteria: November 13, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: IDNA 2009-01