FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR

PHASE3CompletedINTERVENTIONAL
Enrollment

484

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

December 31, 2009

Study Completion Date

April 30, 2010

Conditions
Inflammatory Bowel DiseaseAnemiaIron DeficiencyIron-Deficiency AnemiaCrohn's DiseaseUlcerative Colitis
Interventions
DRUG

Ferric carboxymaltose

Dosage form: 5% w/v iron containing 50 mg iron per mL, as sterile solution of FERINJECT® in water for injection. In case of drip infusion FERINJECT® (10 to 20 ml) must be diluted only in sterile 0.9% sodium chloride (max 250 ml) FERINJECT® will be administered via i.v. drip infusion. Minimum administration time 15 minutes Dosage: 500 mg, 1000 mg, 1500 mg, according to patients' Hb and body weight

DRUG

Iron Sucrose

"VENOFER® will be administered via i.v. drip infusion, diluted only in sterile 0.9% sodium chloride solution as follows:~• 10 mL Venofer® (200 mg iron) in maximum 200 mL sterile 0.9% sodium chloride solution in at least 30 minutes.~The first 25 mL of solution should be infused as a test dose over a period of 15 minutes. If no adverse reactions occur, use infusion rate no more than 50 mL in 15 minutes.~The individual iron deficit will be calculated using the modified formula of Ganzoni.~If the patient's body mass index is \>25, a normalised weight will be used for the calculation of iron deficit. Normalised weight = 25 x height \[m\] x height \[m\].~The calculated cumulative VENOFER® dose is to be rounded up or down to the nearest 200 mg.~Patients will receive one 200 mg VENOFER® infusion, twice a week, up to 11 times (max dosage 2200 mg), depending on their calculated iron deficit."

Trial Locations (1)

1090

AKH Vienna, University clinic of Int Medizin III, Vienna

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

collaborator

ClinStar, LLC

INDUSTRY

lead

Vifor Pharma

INDUSTRY