Safety Assessment of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)

NCT01151592 | Withdrawn Phase 4

• 1 other identifier: 1VEN10034
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the safety and tolerability of Venofer in patients with chronic kidney disease who cannot tolerate Ferumoxytol (Feraheme) or intravenous iron containing a dextran (INFed or Dexferrum).

Conditions

Iron Deficiency Anemia

Keywords

Iron deficiency anemia in Chronic Kidney Disease Patients

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events, overall and related from Day of first iron sucrose administration through the end of the study.

  Day 0 through 30 days after the final administration of iron sucrose

Interventions

Iron Sucrose DRUG

Iron Sucrose, 1000 mg cumulative dose to be administered per the US package insert.

Also known as: Venofer

Eligibility Criteria

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

You may qualify if:

• Male or female subjects \> or = to 18 years of age
• Determined by treating physician to have chronic kidney disease and require a course of intravenous iron
• Subject did not tolerate an intravenous iron containing a dextran or Ferumoxytol within the last year
• Subjects with hemodialysis-dependent or peritoneal dialysis chronic kidney disease should be receiving an erythropoiesis stimulating agent (ESA) as per the iron sucrose package insert

You may not qualify if:

• Known history of hypersensitivity or significant intolerance to iron sucrose
• Evidence of iron overload
• Hemochromatosis or other iron storage disorders
• Received an investigational drug within 30 days of screening
• Any other laboratory abnormality, medical condition or psychiatric disorder which would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
• Pregnant or sexually-active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

Luitpold Pharmaceuticals, Inc.

Norristown, Pennsylvania, 19403, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 28, 2010
• Last Updated: January 24, 2018

Record last verified: 2018-01

Locations

US (1)