Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis
Launched by AMERICAN REGENT, INC. · Oct 10, 2005
Trial Information
Current as of April 26, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility 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.
About American Regent, Inc.
American Regent, Inc. is a leading pharmaceutical company dedicated to the development, manufacturing, and commercialization of high-quality injectable products. With a strong focus on providing essential medications across various therapeutic areas, American Regent aims to improve patient outcomes through innovative solutions and a commitment to quality and safety. The company actively engages in clinical trials to advance its product portfolio and address unmet medical needs, ensuring that healthcare professionals and patients have access to reliable and effective treatments. Through its rigorous research and development efforts, American Regent strives to contribute significantly to the healthcare community and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Mark A Falone, MD
Study Director
American Regent, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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