Anemia
- A Multi-Center, Randomized, COntrolled Study to Investigate the Safety and Tolerability of a Single Dose of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical care in Treating Iron Deficiency Anemia in Subjects Who are not Dyalisis Dependent
- A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Mecical Care in Treating Iron Deficiency Anemia
A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of a Single Dose of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical care in Treating Iron Deficiency Anemia in Subjects Who are not Dyalisis Dependent
Eligibility Criteria (per Protocol dated 05/12/08):
- Iron deficiency.
- Not eligible if there has been previous participation in a ferric carboxymaltose (FCM) clinical trial.
- Not eligible if there is a known hypersensitivity reaction to any component of FCM.
- Not eligible if there is a requirement of dyalisis for treqtment of chronic kidney disease.
- Not eligible if there is current anemia not attributed to iron deficiency.
- Not eligible if there is current or acute or chronic infection other than viral upper respiratory tract infection.
- Not eligible if there is known positive hepatitis B antigen or hepatitis C viral antibody with evidence of active hepatitis.
- Not eligible if there has been alcohol or drug abuse within 6 months prior to study entry.
- Not eligible if there are any other laboratory abnormalities, medical conditions, or psychiatric disorders, which in the opinion of the investigator would put the subject at risk.
- Other criteria, as determined by the protocol.
For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.
A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Mecical Care in Treating Iron Deficiency Anemia
Eligibility Criteria (per Protocol dated 05/12/08):
- Iron deficiency.
- Not eligible if there has been previous participation in a Ferric Carboxymaltose (FCM) clinical trial.
- Not eligible if there is a known hypersensitivity reaction to any component of FCM.
- Not eligible if there is a requirement for dialysis for treatment of chronic kidney disease.
- Not eligible if there is current anmeia not attributed to iron deficiency.
- Not eligible if there is a current or acute or chronic infection other than viral upper respiratory tract infection.
- Not eligible if there is known positive HIV-1/HIV-2 antibodies (anti-HIV).
- Not eligible if the subject is being treated for asthma at the time of study entry.
- Not eligible if the subject has received an investigational drug within 30 days of Screening.
- Other criteria, as determined by the protocol.
For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.