Last reviewed · How we verify
A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
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.
Details
| Lead sponsor | American Regent, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 224 |
| Start date | 2003-02 |
| Completion | 2005-12 |
Conditions
- Anemia
Interventions
- iron sucrose injection USP
- stable erythropoietin therapy
Primary outcomes
- Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21). — During Stage 2 (week 9 through week 21)
The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).