Ferric Carboxymaltose in Subjects With Functional Iron Deficiency Undergoing Chemotherapy (FID-CHEMO)
|ClinicalTrials.gov Identifier: NCT01101399|
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : December 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Iron-Deficiency Anemia||Drug: Ferric carboxymaltose||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Iron Deficiency Receiving Chemotherapy|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2013|
Active Comparator: Ferric carboxymaltose
Subjects will receive a total dose of 1,000 mg iron as FCM on the day of the next scheduled chemotherapy cycle after randomisation or continuous chemotherapy. In subjects with weight ≤66 kg, the first dose iron will be 500 mg; the second dose (500 mg) will be administered on the visit 4 (week 2).
Drug: Ferric carboxymaltose
Subjects will receive a single dose of 1,000 mg iron as FCM infusion at baseline.
Subjects of bw ≤66 kg will receive a single dose of 500 mg iron as FCM infusion at baseline (Week 0) and at Visit 4 (Week 2).
Ferric carboxymaltose will be administered on the same day with chemotherapy treatment or within 24 hours before or after the chemotherapy. For subjects with bw ≤66 kg, if no chemotherapy planned for the visit 4 (Week 2), the second FCM dose should be infused independent of chemotherapy.
Other Name: Ferinject
No Intervention: Local standard of care.
Subjects will be treated according to the local institutional practice.
- Change in haemoglobin from baseline to Week 4 [ Time Frame: Weeks 4 post baseline ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101399
|Hamburg, Germany, 20246|
|Department of Medicine, St Görans Hospital (Capio St Görans Sjukhus)|
|Stockholm, Sweden, SE-112 81|
|Principal Investigator:||Torbjörn Karlsson, MD, PhD||Capio St Görans Sjukhus, Stockholm|
|Study Director:||Morgan McNamara||Vifor Pharma, CH-8152 Glattbrugg, Switzerland|