Ferric Carboxymaltose in Subjects With Functional Iron Deficiency Undergoing Chemotherapy (FID-CHEMO)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|