Trials / Withdrawn
WithdrawnNCT01151592
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)
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- American Regent, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Iron Sucrose | Iron Sucrose, 1000 mg cumulative dose to be administered per the US package insert. |
Timeline
- First posted
- 2010-06-28
- Last updated
- 2018-01-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01151592. Inclusion in this directory is not an endorsement.