Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis(HD) Patients
NCT06690450 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2024-11-15
Summary
The Objective of this study is to assess the Safety and Tolerability of 200 mg and 100 mg of Venofer Administered to Hemodialysis(HD) Patients.
Conditions
- Hemodialysis
Interventions
- DRUG
-
Venofer® 200 mg
A single 200 mg dose of Venofer® administered by slow intravenous push over 5 minutes
- DRUG
-
Venofer® 100 mg
A single 100 mg dose of Venofer® administered by slow intravenous push over 2 minutes without a test dose.
Sponsors & Collaborators
-
American Regent, Inc.
lead INDUSTRY
Principal Investigators
-
Carol Duffy, D.O.,FACC · Medical Director
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-08-31
- Primary Completion
- 2002-01-31
- Completion
- 2002-02-28
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