Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

Anemia Clinical Trial

Official title:

Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236938
• Other study ID #: 1VEN02021 / 1VEN02022
• Status: Completed
• Phase: Phase 3
• Start date: July 2002
• Est. completion date: October 2004

Study information

• Verified date: April 2021
• Source: American Regent, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.

Description:

This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. Erythropoietin regimen was to remain stable. Patients were followed to day 71 for safety and efficacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: October 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hemoglobin >= 9.5 and <= 11.5 g/dL.

• Ferritin <= 500 ng/ml.

• Serum Transferrin Saturation (TSAT) <= 25%.

• Stable erythropoietin (EPO) Regimen for 8 weeks.

• No iron for last 4 weeks before randomization.

Exclusion Criteria:

• Known Sensitivity to Iron Sucrose.

• Suffering concomitant severe diseases of the liver & cardiovascular system.

• Pregnancy / Lactation.

• Inadequate dialysis.

• Current treatment for asthma.

• Significant blood loss.

• Probability of need for transfusion or transfusion within 1 week of enrollment.

• Anticipated major surgery.

• Hemochromatosis / hemosiderosis.

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Venofer and stable erythropoietin (EPO) regimen
Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
• stable erythropoietin (EPO) regimen
Stable erythropoietin (EPO) dose and no supplemental iron.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
American Regent, Inc.

References & Publications (1)

Singh H, Reed J, Noble S, Cangiano JL, Van Wyck DB; United States Iron Sucrose (Venofer) Clinical Trials Group. Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythropoiesis-stimulating agents for anemia: a randomized, controlled trial. Clin J Am Soc Nephrol. 2006 May;1(3):475-82. Epub 2006 Mar 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline to the Highest Hemoglobin up to Day 71		Change from Baseline up to Day 71
Secondary	The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71		Change from Baseline up to Day 71
Secondary	The Mean Change From Baseline to the Highest Ferritin up to Day 71		Change from Baseline up to Day 71
Secondary	The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71		Change from Baseline up to Day 71