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

American Regent

Status and phase: Completed; Phase 4

Conditions: Hemodialysis

Treatments: Drug: Venofer® 100 mg; Drug: Venofer® 200 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06690450

1VEN01015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Venofer® 200 mg

Experimental group

Description:

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

Treatment:

Drug: Venofer® 200 mg

Venofer® 100 mg

Active Comparator group

Description:

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

Treatment:

Drug: Venofer® 100 mg