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

This study has been completed.
Sponsor:
Collaborator:
SGS
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT01110356
First received: April 22, 2010
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Iron Deficiency
Drug: Ferinject
Other: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: Day 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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%). [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
  • To determine the relationship between change in iron status (s-ferritin and TfS) and improvement of fatigue symptoms. [ Time Frame: Day 56 ] [ Designated as safety issue: No ]

Enrollment: 294
Study Start Date: June 2010
Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Ferinject
Placebo Comparator: Saline Other: Saline
Placebo patients will be administered 250 mL normal saline for intravenous drip over a minimum of 15 minutes.
Other Name: Saline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110356

Locations
Austria
Universitätsklinik für Frauenheilkunde
Vienna, Austria, 1090
Sponsors and Collaborators
Vifor Inc.
SGS
Investigators
Principal Investigator: Bernard Favrat Quartier UNIL-CHUV
  More Information

No publications provided by Vifor Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT01110356     History of Changes
Other Study ID Numbers: IDNA 2009-01
Study First Received: April 22, 2010
Last Updated: November 13, 2012
Health Authority: Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
Switzerland: Swissmedic

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014