Treatment of iron deficient non anaemic women with ferric carboxymaltose. MedDRA version: 12.1 Level: LLT Classification code 10022970 Term: Iron deficiency
Conditions
Interventions
Trade Name: Ferinject®
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ferric carboxymaltose (FCM
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentrat
Sponsors
Vifor Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent prior to study specific procedures. 2. Premenopausal, regularly menstruating women. 3. Age =18 years. 4. Body weight between 50 and 90 kg. 5. Haemoglobin =115 g/L. 6. Iron deficiency at screening defined as follows: - S-ferritin level =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Haemoglobin level 3-fold upper limit), angina (Class IV). 6. Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection. 7. Chronic inflammatory disease (e.g., rheumatoid arthritis; inflammatory bowel disease). 8. Documented history of clinically significant level of sleep apnoea defined as 5 or more episodes per hour of any type of apnoea. 9. 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). 10. Important recent weight loss (>10% within the past month). 11. Body weight 90 kg. 12. Thyroid dysfunction, thyroid stimulating hormone >4 µU/mL. 13. Intake of iron preparations 4 weeks prior to screening. 14. Use of gestagens e.g., Implanon® Mirena®, Depo- Provera® for menstruation repression (see Section 7.7, Prohibited Therapy or Concomitant Treatment, page 35). 15. Known hypersensitivity to FCM or to any other iron preparation. 16. Pregnancy (positive hCG test at screening) or breast feeding. 17. Participation in any other interventional trial within 4 weeks prior to screening. 18. Inability to fully comprehend and/or perform study procedures or provide written consent in the Investigator’s opinion. 19. 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. 20. Subject previously has entered this study. 21. Subject will not be available for follow-up assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: • 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%). • To determine the relationship between change in iron status (s-ferritin and TfS) and improvement of fatigue symptoms. • To compare the efficacy of a single IV administration of FCM with that of placebo in improving cognitive function (attention, concentration and short-term memory). • To assess the safety of single IV administration of FCM.;Primary end point(s): The proportion of responders defined as subjects who have a decrease in total score of PFS (mean of items 2 to 23) of at least 1 point from baseline on Study Day 56. | — |
Countries
Austria, Germany, Sweden
Outcome results
None listed