Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01101399
Study type Interventional
Source Vifor Inc.
Contact
Status Completed
Phase Phase 3
Start date May 2010
Completion date November 2013

See also
  Status Clinical Trial Phase
Completed NCT04949165 - Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study N/A
Active, not recruiting NCT02541708 - IV Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Iron Deficiency Anemia at Delivery in Tanzania Phase 3
Completed NCT01942460 - Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients Phase 4
Completed NCT01047098 - Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation N/A
Completed NCT00810030 - FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR Phase 3
Completed NCT00298051 - Umbilical Cord Clamping and Infant Iron Status N/A
Completed NCT01135576 - Iron Fortified Beverages and Application in Women Predisposed to Anemia N/A
Withdrawn NCT04320966 - Neurovascular Complications and White Matter Damage in Acquired Anemias
Completed NCT05240677 - Endoscopy in CKD With Iron Deficiency Anemia N/A
Terminated NCT01100879 - Ferric Carboxymaltose for Treatment of Anaemia of Cancer in Subjects With Multiple Myeloma Receiving Chemotherapy Phase 4
Recruiting NCT02487719 - Different Iron Supplements for Prevention of Anemia in Pregnancy Phase 4
Recruiting NCT03232554 - Buxue Yimu Pills for Gynecological Iron-Deficiency Anemia Phase 2
Terminated NCT02341300 - Use of Cast Iron Pots to Improve Maternal Anemia N/A
Completed NCT04318405 - Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery (Real-CHOICE).
Completed NCT02998697 - Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia Phase 2/Phase 3
Not yet recruiting NCT03411590 - The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers N/A
Completed NCT05365308 - EHR-based Patient Identification and Panel Management of Patients With Iron Deficiency Anemia N/A
Recruiting NCT01071759 - Effects of Dietary Heme/Non-heme Iron and Helicobacter Pylori (Hp) Infection on Maternal Iron-deficiency Anemia and Fetal Growth Outcomes N/A
Terminated NCT00882414 - Ferinject® in Patient With Thrombocytosis Secondary to Inflammatory Bowel Disease (IBD) Phase 2
Completed NCT02968368 - Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease Phase 3