Trial Details

Not Recruiting
Basic Information
Clinical ID c3009
Identifier ISRCTN82615441
Trial Title A multi-centre, randomised, controlled, phase iii study to investigate the safety and efficacy of intravenous infusions of VIT-45 in patients with iron deficiency anaemia secondary to chronic inflammatory bowel disease
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Iron deficiency anaemia secondary to chronic inflammatory bowel disease Signs and Symptoms
Interventions 1. Patients in the experimental arm received VIT-45 as an infusion on Day 1, with subsequent infusions at weekly intervals up to a maximum of 1000 mg iron per dose. The doses were continued until the patient received the cumulative dose based on their individual requirement for iron. A maximum of three infusions were permitted in a single treatment cycle 2. Patients in the control arm of the study received ferrous sulfate capsules (100 mg iron), one to be taken BID for 12 weeks (total daily dose 200 mg iron)
Participant Information
Sponsor Vifor (International) Inc.
City -
Country/Region Argentina;Austria;Belgium;Bulgaria;Mexico;Poland;Russia;Ukraine
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Interventional
Phase PHASE3
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -