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WithdrawnNCT01151592ASSUREDUpdated Jan 24, 2018

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

A Phase 4 interventional study of Iron Sucrose in Iron Deficiency Anemia, sponsored by American Regent, Inc.. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-24.

Sponsored by American Regent, Inc. · Phase 4, Interventional, and Treatment

Why this study was withdrawn
Sponsor Decision
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Iron Deficiency Anemia

Keywords

  • Iron deficiency anemia in Chronic Kidney Disease Patients
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

Browse Kidney Diseases studies →

Lead sponsor

American Regent, Inc. is the lead sponsor of 53 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • DrugIron Sucrose

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

    Also known as: Venofer

06

What researchers measure

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.

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

07

Study locations

1 site
  • Luitpold Pharmaceuticals, Inc.
    Norristown, Pennsylvania 19403, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01151592
Lead sponsor
American Regent, Inc.
Responsible party
Sponsor
First posted
Jun 28, 2010
Last update
Jan 24, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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