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

NCT ID: NCT06690450

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2002-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venofer® 200 mg

A single 200 mg dose of Venofer® administered by slow intravenous push over 5 minutes.

Group Type: EXPERIMENTAL

Venofer® 200 mg

Intervention Type: DRUG

A single 200 mg dose of Venofer® administered by slow intravenous push over 5 minutes

Venofer® 100 mg

A single 100 mg dose of Venofer® administered by slow intravenous push over 2 minutes without a test dose

Group Type: ACTIVE_COMPARATOR

Venofer® 100 mg

Intervention Type: DRUG

A single 100 mg dose of Venofer® administered by slow intravenous push over 2 minutes without a test dose.

Interventions

Venofer® 200 mg

A single 200 mg dose of Venofer® administered by slow intravenous push over 5 minutes

Intervention Type: DRUG

Venofer® 100 mg

A single 100 mg dose of Venofer® administered by slow intravenous push over 2 minutes without a test dose.

Intervention Type: DRUG

Other Intervention Names

Iron sucrose; Iron sucrose

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Regent, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carol Duffy, D.O.,FACC

Role: STUDY_DIRECTOR

Medical Director

Other Identifiers

1VEN01015

Identifier Type: -

Identifier Source: org_study_id