Phase 3 N=250 Randomized Treatment

VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Anemia

Bottom Line

View on ClinicalTrials.gov: NCT00317239 ↗

Enrolled (actual)

250

Serious AEs

9.2%

Results posted

Nov 2013

Primary outcome: Primary: Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL — 87; 35 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ferrous Sulfate tablets (Drug); Ferric Carboxymaltose (FCM) (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: American Regent, Inc.
Primary completion: Feb 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL	87; 35	—

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).

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

View full record on ClinicalTrials.gov →

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.