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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Anemia	Drug: Venofer and stable erythropoietin (EPO) regimen; Drug: stable erythropoietin (EPO) regimen	Phase 3

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	121 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis
Study Start Date :	July 2002
Actual Primary Completion Date :	September 2004
Actual Study Completion Date :	October 2004

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Group A; 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.	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.; Other Name: Iron Sucrose
Active Comparator: Group B; Stable erythropoietin (EPO) dose and no supplemental iron.	Drug: stable erythropoietin (EPO) regimen; Stable erythropoietin (EPO) dose and no supplemental iron.; Other Name: EPO

Outcome Measures

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Primary Outcome Measures :

1. Mean Change From Baseline to the Highest Hemoglobin up to Day 71 [ Time Frame: Change from Baseline up to Day 71 ]

Secondary Outcome Measures :

1. The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71 [ Time Frame: Change from Baseline up to Day 71 ]
2. The Mean Change From Baseline to the Highest Ferritin up to Day 71 [ Time Frame: Change from Baseline up to Day 71 ]
3. The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71 [ Time Frame: Change from Baseline up to Day 71 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Sponsors and Collaborators

Luitpold Pharmaceuticals

Investigators

Study Director:	Mark A Falone, MD	Luitpold Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

Responsible Party:	Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00236938 History of Changes
Other Study ID Numbers:	1VEN02021 / 1VEN02022
First Posted:	October 12, 2005
Results First Posted:	September 7, 2009
Last Update Posted:	February 20, 2018
Last Verified:	January 2018

Keywords provided by Luitpold Pharmaceuticals:

iron; peritoneal dialysis; anemia

Additional relevant MeSH terms:

Iron; Ferric oxide, saccharated; Epoetin Alfa; Ferric Compounds; Trace Elements	Micronutrients; Growth Substances; Physiological Effects of Drugs; Hematinics