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Sponsored by: |
Luitpold Pharmaceuticals |
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Information provided by: | Luitpold Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00236938 |
This is a open-label, prospective study comparing IV iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.
Condition | Intervention | Phase |
---|---|---|
Anemia |
Drug: iron sucrose injection USP Drug: Stable Erythropoietin Regimen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis |
Estimated Enrollment: | 129 |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | October 2004 |
This is a open-label, prospective study comparing IV iron supplementation to standard care in anemic patents 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 for to day 71 for safety and efficacy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 1VEN02021 / 1VEN02022 |
Study First Received: | October 10, 2005 |
Last Updated: | October 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00236938 |
Health Authority: | United States: Food and Drug Administration |
iron peritoneal dialysis anemia |
Epoetin Alfa Ferric oxide, saccharated Hematologic Diseases Anemia Iron |
Hematinics Growth Substances Therapeutic Uses Physiological Effects of Drugs |
Hematologic Agents Trace Elements Micronutrients Pharmacologic Actions |