Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:2/22/2018
Start Date:August 2003
End Date:October 2004

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Trial Summary
Trial Overview
Inclusion Criteria

Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

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.

Inclusion Criteria:

- Hemoglobin < or = 11.5 gm/dL

- Stable dose or not receiving EPO

- Renal Anemia

Exclusion Criteria:

- IV iron with last 6 months

- Chronic infection, malignancy,major surgery within last month

- Blood Transfusion with last two months

- Significant blood loss within last 3 months

- Concomitant sever diseases of the liver
We found this trial at
1
site
Luitpold Pharmaceuticals
800 Adams Avenue
Valley Forge, Pennsylvania 19403
?
mi
from
Valley Forge, PA
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