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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236964
• Other study ID #: 1VEN99012
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2005
• Last updated: January 22, 2018
• Start date: February 2001
• Est. completion date: May 2002

Study information

• Verified date: January 2018
• Source: Luitpold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Creatine Clearance <40 mL/min

• Average Baseline Hemoglobin < 10.5g/dL

• 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

Related Conditions & MeSH terms

• Anemia
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Iron Sucrose + Erythropoietin

• Ferrous Sulfate + Erythropoietin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Luitpold Pharmaceuticals

References & Publications (1)

Charytan C, Qunibi W, Bailie GR; Venofer Clinical Studies Group. Comparison of intravenous iron sucrose to oral iron in the treatment of anemic patients with chronic kidney disease not on dialysis. Nephron Clin Pract. 2005;100(3):c55-62. Epub 2005 Apr 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Hemoglobin and Serum Ferritin at day 43
Secondary	Clinical success (change in Hgb > 12 & Change in Ferritin 180)
Secondary	Maximum change in Hemoglobin during the study