This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
146
125 mg weekly x 8 weeks
250 mg weekly x 4
325 mg ferrous sulfate orally three times daily x 8 weeks
Hemoglobin
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Time frame: Baseline to 5 weeks and 9 weeks
Change From Baseline in Hematocrit (Hct)
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Time frame: Baseline to 5 weeks and 9 weeks
Change From Baseline in Transferrin Saturation (TSAT).
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Time frame: Baseline to 5 weeks and 9 weeks
Change From Baseline in Serum Ferritin.
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Time frame: Baseline to 5 weeks and 9 weeks
Responders by Treatment Group
Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron.
Time frame: Baseline to 5 weeks and 9 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Birmingham, Alabama, United States
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Mesa, Arizona, United States
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Los Angeles, California, United States
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Torrance, California, United States
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New Haven, Connecticut, United States
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Evanston, Illinois, United States
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Shreveport, Louisiana, United States
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Springfield, Massachusetts, United States
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Worcester, Massachusetts, United States
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Royal Oak, Michigan, United States
...and 33 more locations