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

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

Sponsors

Lead Sponsor: American Regent, Inc.

Source American Regent, Inc.
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).

Detailed Description

This is a Phase IV, multi-center, open label study that assesses the safety and tolerability of Iron Sucrose (Venofer) in subjects with CKD who require intravenous iron for the treatment of iron deficiency anemia (IDA) but cannot tolerate Ferumoxytol or Iron Dextran.

Overall Status Withdrawn
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Condition
Intervention

Intervention Type: Drug

Intervention Name: Iron Sucrose

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

Other Name: Venofer

Eligibility

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: Luitpold Pharmaceuticals, Inc.
Location Countries

United States

Verification Date

January 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym ASSURED
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov