Phase 3
N=224
Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00236951 ↗Enrolled (actual)
224
Serious AEs
21.9%
Results posted
Sep 2009
Primary outcome: Primary: Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21). — 2.6; 1.8; 2.5; 1.3 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- iron sucrose injection USP (Drug); stable erythropoietin therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- American Regent, Inc.
- Primary completion
- Oct 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21). |
2.6; 1.8; 2.5; 1.3 | — |
Summary
To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.
Eligibility Criteria
Inclusion Criteria
- Histological Diagnosis of Cancer
- Hgb 50kg
- Free of Active Infection
- Karnofsky Status 60% to 100%
Exclusion Criteria
- Active infection
- Use of Multivitamins with iron within one week of entry
- Myelophthisic bone marrow involvement by tumor except hematologic malignancy
- Concurrent medical condition that would prevent compliance or jeopardize the health of the patient
- Use of any IV iron products within two months of study entry
- Blood Transfusions
- Hypoplastic bone marrow failure state
- Acute Leukemia
- Myeloproliferative syndrome
- Uncontrolled hypertension
Data sourced from ClinicalTrials.gov (NCT00236951). 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.