CompletedPhase 3

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

96 participantsStarted 2001-02-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mean Change in Hemoglobin

Timeframe: Baseline and Day 43

Mean Change in Serum Ferritin

Timeframe: Baseline and Day 43

Trial details

NCT IDNCT00236964

SponsorAmerican Regent, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2002-05-30

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