Anemia
Conditions
Keywords
Anemia, Chronic Kidney Disease
Brief summary
The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis.
Detailed description
Randomized open-label multicenter active-controlled study of anemic patients with Chronic Renal Failure who are not yet receiving dialysis. The duration of the study was five months. After screening procedures including multiple hemoglobin values, patients were randomly assigned to either IV Iron Sucrose (200mg X 5) or oral iron sulfate (325mg TID)for 29 days. Safety assessments included the recording of all adverse events, physical examinations, vital signs, electrocardiograms and clinical laboratory tests. Efficacy parameters included hematologic parameters.
Interventions
DRUGIron Sucrose + Erythropoietin
The total dose of iron sucrose was 1,000 mg. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36.
DRUGOral Iron + Erythropoietin
Oral iron 325 mg three time daily for 29 days. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36.
Sponsors
American Regent, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Creatine Clearance \<40 mL/min * Average Baseline Hemoglobin \< 10.5g/dL * Serum Transferrin Saturation (TSAT) \< 25% and Ferritin \<300ng/mL
Exclusion criteria
* Blood Transfusion within 30days * Uncontrolled Hypertension * Suffering form concommitant disease of the liver * Serious bacterial infection * Pregnancy / lactation * Symptomatic HIV * Expected to under dialysis or renal transplant during study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Hemoglobin | Baseline and Day 43 | Change in hemoglobin g/dL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA). |
| Mean Change in Serum Ferritin | Baseline and Day 43 | Change in Ferritin ng/mL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success (Change in Hemoglobin) | Baseline and Day 43 | Participants were considered to have achieved clinical success if they attained a change in hemoglobin ≥0.8 g/dL. The difference from baseline to Day 43 was calculated and rounded. |
| Clinical success (change in Ferritin) | Baseline and Day 43 | Participants were considered to have achieved clinical success if they attained a change in ferritin ≥160 ng/mL. The difference from baseline to Day 43 was calculated and rounded. |
Outcome results
None listed