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Safety of Venofer 200mg vs 100mg in Hemodialysis Patients
NCT06690450Phase 4
Key facts
- Status
- Completed
- Start
- Aug 2001
- Primary completion
- Jan 2002
- Sponsor
- American Regent, Inc.
- Modality
- Small Molecules
- Drugs
- iron sucrose
- Conditions
- iron deficiency anemia (IDA)
01
Overview
Phase 4, randomised, open-label trial of iron sucrose in iron deficiency anemia (IDA) (2 arms), sponsored by American Regent, Inc. Primary endpoint: Treatment-Emergent Adverse Events. Started Aug 2001; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Venofer 200 mg
Single 200 mg dose IV push over 5 mins
Venofer 100 mg
Single 100 mg dose IV push over 2 mins
03
Endpoints
Primary
Treatment-Emergent Adverse Events
Secondary
Premature Discontinuation due to Adverse Event
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