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

Sponsored by:	Luitpold Pharmaceuticals
Information provided by:	Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00236938

Purpose

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

MedlinePlus related topics: Anemia Kidney Failure

Drug Information available for: Epoetin alfa Erythropoietin Sucrose Ferric oxide, saccharated

U.S. FDA Resources

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

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:

The primary efficacy endpoint was the mean change from baseline to the highest Hgb.

Secondary Outcome Measures:

The mean change from baseline to the highest TSAT
The mean change from baseline to the highest Ferritin
The mean change from baseline to the highest Reticulocyte Count.

Estimated Enrollment:	129
Study Start Date:	July 2002
Estimated Study Completion Date:	October 2004

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hgb >/= 9.5 and </= 11.5
ferritin </= 500ng/ml
TSAT </= 25%
Stable 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

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

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

Keywords provided by Luitpold Pharmaceuticals:

iron
peritoneal dialysis
anemia

Study placed in the following topic categories:

Epoetin Alfa
Ferric oxide, saccharated
Hematologic Diseases
Anemia
Iron

Additional relevant MeSH terms:

Hematinics
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs

Hematologic Agents
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009