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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis
• Intervention / Treatment: Drug: Venofer® 200 mg; Drug: Venofer® 100 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Males or females over 18 years of age and able to give informed consent.
• Undergoing hemodialysis.
• If receiving epoetin α, then the dose was stable.
• Percentage serum transferrin saturation (TSAT) <50% and serum ferritin <800 ng/mL.
• Absence of infection, malignancy, or surgery in the month prior to study start.
• Intolerance of other iron products did not preclude participation in this study.

Exclusion Criteria:

• Known sensitivity to any component of Venofer®.
• Suffering from concomitant severe diseases of the liver, cardiovascular system, severe psychiatric disorders or other conditions which, in the opinion of the investigator, made participation unacceptable.
• Serious bacterial, viral infection, or other acute infectious illness (e.g., hepatitis) unless completely resolved at least 4 weeks prior to inclusion in the study.
• Pregnancy or lactation.
• HIV positive by medical history or laboratory test (optional), or active hepatitis.
• Anemia caused by diseases (including systemic lupus erythematosus (SLE), rheumatoid arthritis, myeloma, or hereditary hemoglobinopathies) other than chronic renal failure or iron deficiency.
• Asthma.
• Clinical evidence of gastrointestinal bleeding.
• Would probably require blood transfusion or might undergo a renal transplant during the study.
• Anticipated surgery of any kind during the study other than vascular access surgery.
• Received an investigational drug within 30 days prior to screening.
• Previously participated in another Venofer® study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Venofer® 200 mg; A single 200 mg dose of Venofer® administered by slow intravenous push over 5 minutes.	Drug: Venofer® 200 mg; A single 200 mg dose of Venofer® administered by slow intravenous push over 5 minutes; Other Names: Iron sucrose
Active Comparator: Venofer® 100 mg; A single 100 mg dose of Venofer® administered by slow intravenous push over 2 minutes without a test dose	Drug: Venofer® 100 mg; A single 100 mg dose of Venofer® administered by slow intravenous push over 2 minutes without a test dose.; Other Names: Iron sucrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.0	Any untoward medical events were elicited by nonspecific questions such as "Have you noticed any problems".	3 to 6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants prematurely discontinued the study due to an adverse event	The investigator determined whether any adverse event warranted removal of a subject from the study	3 to 6 days

Collaborators and Investigators

• Sponsor: American Regent, Inc.
• Investigators: Study Director: Carol Duffy, D.O.,FACC, Medical director

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2001
• Primary Completion (Actual): January 1, 2002
• Study Completion (Actual): February 1, 2002

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Hematinics; Ferric Oxide, Saccharated; Iron
• Other Study ID Numbers: 1VEN01015