Clinical Trial: Ferric Carboxymaltose in Subjects With Functional Iron Deficiency Undergoing Chemotherapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomised Controlled Open-label Study to Evaluate Efficacy & Safety of Intravenous Ferric Carboxymaltose Versus no Treatment in Anaemic Subjects With Lymphoid Malignancies & Functional

Brief Summary: Anaemia and functional iron deficiency are common conditions in patients with lymphoid malignancies, conditions which reduce significantly the quality of life and increase morbidity and mortality. Traditionally, Erythropoiesis Stimulating Agents (ESAs) have been used, but recently their use has been shown to have a negative impact on overall survival in different oncology populations. Recently published data suggest that intravenous (IV) iron can be effective in anaemia treatment, even without ESAs. This exploratory study is the first clinical project with ferric carboxymaltose (FCM) in patients with lymphoid malignancies: the data generated may be used for further evaluations of the drug in larger populations. In this study, 1,000 mg of IV iron as FCM will be administered on the same day or within 24 hours before or after chemotherapy treatment. The primary objective is to evaluate the efficacy of FCM in the correction of haemoglobin levels in anaemic subjects with lymphoid malignancies, undergoing chemotherapy. Secondary objectives aim to describe the safety and tolerability of FCM, and the effect of FCM treatment on iron status variables in subjects suffering from lymphoid malignancies.

Detailed Summary: Multicentre, randomised, controlled, 2-arm open-label prospective pilot study to evaluate efficacy and safety of FCM in the treatment of anaemia in LPD subjects with functional iron deficiency (FID), undergoing chemotherapy. The subjects will be screened for eligibility within 4 weeks prior to inclusion to receive intravenous (IV) infusions of FCM or no FCM infusions (the subjects may be treated according to the local institutional practice if requiring symptomatic management of anaemia). After randomisation, the visits are scheduled weekly until Week 8.
Sponsor: Vifor Inc.

Current Primary Outcome: Change in haemoglobin from baseline to Week 4 [ Time Frame: Weeks 4 post baseline ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The percentage of subjects with blood haemoglobin increase of at least 1 g/dL in the absence of any red cell transfusion or ESA treatment. [ Time Frame: 12 weeks post baseline ]
  • Change in haemoglobin from baseline to Week 6 [ Time Frame: 6 weeks after baseline ]
  • Change in haemoglobin from baseline to Week 8 [ Time Frame: 8 weeks after baseline ]


Original Secondary Outcome: Same as current

Information By: Vifor Inc.

Dates:
Date Received: March 30, 2010
Date Started: May 2010
Date Completion:
Last Updated: December 16, 2013
Last Verified: December 2013