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

NCT06690450 | Completed Phase 4 DMC

• 1 other identifier: 1VEN01015
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The number of participants prematurely discontinued the study due to an adverse event

  3 to 6 days

Study Arms (2)

Venofer® 200 mg

EXPERIMENTAL

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

Drug: Venofer® 200 mg

Venofer® 100 mg

ACTIVE COMPARATOR

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

Drug: Venofer® 100 mg

Interventions

Venofer® 200 mg DRUG

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

Also known as: Iron sucrose

Venofer® 200 mg

Venofer® 100 mg DRUG

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

Also known as: Iron sucrose

Venofer® 100 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• American Regent, Inc.: lead

MeSH Terms

Interventions

Ferric Oxide, Saccharated

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Carol Duffy, D.O.,FACC

  Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: November 15, 2024
• Study Start: August 1, 2001
• Primary Completion: January 1, 2002
• Study Completion: February 1, 2002
• Last Updated: November 15, 2024

Record last verified: 2024-11