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

Purpose

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

Condition	Intervention	Phase
Anemia	Drug: Venofer and stable erythropoietin (EPO) regimen Drug: stable erythropoietin (EPO) regimen	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

Resource links provided by NLM:

MedlinePlus related topics: Anemia Iron

Drug Information available for: Sucrose Epoetin Alfa

U.S. FDA Resources

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:

Mean Change From Baseline to the Highest Hemoglobin up to Day 71 [ Time Frame: Change from Baseline up to Day 71 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
The Mean Change From Baseline to the Highest Ferritin up to Day 71 [ Time Frame: Change from Baseline up to Day 71 ] [ Designated as safety issue: No ]
The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71 [ Time Frame: Change from Baseline up to Day 71 ] [ Designated as safety issue: No ]


Enrollment:	121
Study Start Date:	July 2002
Study Completion Date:	October 2004
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236938

Sponsors and Collaborators

Luitpold Pharmaceuticals

Investigators


Study Director:	Antoinette Mangione, MD, PharmD	Luitpold Pharmaceuticals

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
Study First Received:	October 10, 2005
Results First Received:	January 14, 2009
Last Updated:	May 11, 2015
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 29, 2016