Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis

American Regent, Inc.96 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

Iron Sucrose + ErythropoietinDRUG

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.

Oral Iron + ErythropoietinDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mean Change in Hemoglobin

Change in hemoglobin g/dL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).

Time frame: Baseline and Day 43

Mean Change in Serum Ferritin

Change in Ferritin ng/mL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).

Time frame: Baseline and Day 43

Secondary Outcomes

Clinical Success (Change in Hemoglobin)

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.

Time frame: Baseline and Day 43

Clinical success (change in Ferritin)

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.

Time frame: Baseline and Day 43

Data from ClinicalTrials.gov

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