Phase 3
Completed N=250
VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Source: ClinicalTrials.gov NCT00317239 ↗Enrolled (actual)
250
Serious AEs
9.2%
Results posted
Nov 2013
Primary outcomePrimary: Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL — 87; 35 participants
Summary
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL |
87; 35 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females > or = 12 years of age
- NDD-CKD subjects
- Baseline hemoglobin < or = 11g/dl
- Stable erythropoietin (EPO) status
Exclusion Criteria
- Known hypersensitivity to ferrous sulfate or IV iron
- Unstable EPO status
- Anemia not related to CKD
- Chronic, serious infection
- Recent IV iron
- Recent blood transfusion
- Recent blood loss
- Need for surgery
- Received investigational drug within 30 days
- Female subjects who are pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT00317239). 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. Informational only — not medical advice.