Phase 3
N=594
Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00740246 ↗Enrolled (actual)
594
Serious AEs
0.5%
Results posted
Apr 2025
Primary outcome: Primary: Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period — 174; 114 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- VIT-45 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- American Regent, Inc.
- Primary completion
- Feb 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period |
174; 114 | — |
Summary
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
Eligibility Criteria
Inclusion Criteria
- Subjects > or = 18 years of age and able to give informed consent
- Historical laboratory Hgb indicative of anemia within 3 months prior to screening visit
- Screening Visit laboratory Hgb indicative of anemia
- Screening Visit ferritin indicative of iron deficiency anemia
Exclusion Criteria
- Known hypersensitivity to VIT-45
- Previously received VIT-45
- Parenteral iron in the 4 weeks prior to screening
- Chronic or serious active infection
- Malignancy history
- Aspartate aminotransferase (AST) or Alanine transaminase( ALT) greater than the upper limit of normal
- Anticipated need for surgery or initiation of dialysis during the study
- Pregnant or sexually active females who are not willing to use an effective form of birth control
Data sourced from ClinicalTrials.gov (NCT00740246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.