To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.
The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not receiving erythropoietin. After an extensive enrollment period, patients were randomized to receive oral iron (ferrous sulfate, 325mg three times daily (TID) for 56 days) or IV iron sucrose (total 1000mg, 500mg X 2 OR 200mg X 5 within two weeks). Erythropoietin schedule was to remain unchanged during the 56 day study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
oral iron tablets; 325 mg three times a day orally for 56 days
Luitpold Pharmaceuticals
Valley Forge, Pennsylvania, United States
Patients With an Increase in Hemoglobin >= 1gm/dL.
Time frame: Change from Baseline up to Day 56
Number of Subjects With a Clinical Response
Clinical Response (change in Hemoblobin (Hgb) \>= 1gm/dL and change in ferritin \>= 160ng/ml)
Time frame: Change from Baseline up to Day 56
Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56
Time frame: Change from Baseline up to Day 56
Highest Change From Baseline in Ferritin (ng/mL) up to Day 56
Time frame: Change from Baseline up to Day 56
Mean Change in Ferritin (ng/mL) From Baseline to Day 56
Time frame: Change from Baseline at Day 56
Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56
Time frame: Change from Baseline at Day 56
Mean Change From Baseline in Hemoglobin (g/dL) at Day 56
Time frame: Change from Baseline at Day 56
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