NCT06690450

Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis(HD) Patients

A Randomized Study to Assess the Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis (HD) Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized open label multi-center study of two parallel patient groups undergoing hemodialysis. Group A will receive 200 mg of iron sucrose, while Group B will receive 100 mg of iron sucrose during the study. The duration of the study for each patient will be approximately 3 weeks including a screening phase, a treatment visit and a follow-up visit.

Conditions

• Hemodialysis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2001-08-01
• Primary completion: 2002-01-01
• Completion: 2002-02-01
• First posted: 2024-11-15
• Last updated: 2024-11-15