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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vifor Inc.; Vifor Pharma
• Collaborator: SGS S.A.
• Treatments: Ferric Compounds

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.