A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
This was a two stage, randomized, controlled study of cancer patients undergoing or planning
to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis
stimulating agent), patients were randomized to receive either IV iron sucrose or no iron
supplementation. Patients were then followed to safety and efficacy endpoints.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Change From Baseline to the Maximum Hemoglobin Level 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).
During Stage 2 (week 9 through week 21)
United States: Food and Drug Administration