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

NCT00810030 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 484

Last updated 2012-12-21

No results posted yet for this study

Summary

The purpose of this study is to determine how safe, tolerable and effective the new standardised dosage regimen of FERINJECT® infusions is, compared with a well established intravenous iron treatment.

Conditions

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.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • ClinStar, LLC

    collaborator INDUSTRY

  • Vifor Pharma

    lead INDUSTRY

Principal Investigators

  • Christoph Gasche, Professor · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-12-31
Completion
2010-04-30

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00810030 on ClinicalTrials.gov