2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-Deficiency Anemia in Peritoneal Dialysis Patients.
Information source: Watson Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Iron Deficiency Anemia
Intervention: Sodium Ferric Gluconate Complex in Sucrose 125 mg (Drug); Sodium Ferric Gluconate Complex in Sucrose 250 mg (Drug); Oral Iron (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Watson Pharmaceuticals Official(s) and/or principal investigator(s):
Gary Hoel, RPh, PhD, Study Chair, Affiliation: Watson Pharmaceuticals
Summary
This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and
provide signed informed consent will be randomized to receive one of two levels of Ferrlecit
or oral iron in a 1: 1:1 ratio.
Clinical Details
Official title: A Multi-Center, Randomized, Open Label Study of the Efficacy and Safety of Two Doses of Ferrlecit Versus Oral Iron to Treat Iron-Deficiency Anemia in Peroneal Dialysis Patients Receiving Erythropoietin.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Comparison of two doses of Ferrlecit versus oral iron.
Secondary outcome: Compassion between treatments - change from baseline in hematological parameters, number and percentage of patients classified as responders/nonresponders and safety.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female, at least 18 years of age.
- Received maintenance peritoneal dialysis therapy for at least 4 weeks.
- Was expected to remain on peritoneal dialysis therapy for duration of study.
- Had a predetermined low hemoglobin and TSAT levels.
- Signed patient informed consent.
Exclusion Criteria:
- Had a predetermined serum levels of Ferritin and TSAT
- Pregnant or lactating.
- Had a serious concomitant medical disorder incompatible with participation in the
study.
- Had a known hypersensitivity to Ferrlecit or any of its components.
- Unable to cooperate or comply with the protocol.
Locations and Contacts
SOFIA, Bulgaria
VARNA, Bulgaria
KITCHENER, Canada
KELOWNA, Canada
TORONTO, Canada
LONDON, Canada
SCARBOROUGH, Canada
ZAGREB, Croatia
CHENNAI, India
BANGALORE, India
NEW DELHI, India
HYDERABAD, India
LUCKNOW, India
CHANDIGARH, India
MAHIM, India
ZAPOPAN, Mexico
TLALPAN, Mexico
MONTERREY, Mexico
DURANGO, Mexico
COL. TORIELLO GUERRA, Mexico
MEXICO CITY, Mexico
OSIJEK, Poland
MOSCOW, Russian Federation
ST. PETERSBURG, Russian Federation
BIRMINGHAM, Alabama, United States
MESA, Arizona, United States
LOS ANGELES, California, United States
TORRANCE, California, United States
NEW HAVEN, Connecticut, United States
EVANSTON, Illinois, United States
SHREVEPORT, Louisiana, United States
WORCESTER, Massachusetts, United States
SPRINGFIELD, Massachusetts, United States
ROYAL OAK, Michigan, United States
ST. LOUIS, Missouri, United States
NEW YORK, New York, United States
WINSTON-SALEM, North Carolina, United States
CHAPEL HILL, North Carolina, United States
TULSA, Oklahoma, United States
PHILADELPHIA, Pennsylvania, United States
SIOUX FALLS, South Dakota, United States
DALLAS, Texas, United States
RICHMOND, Virginia, United States
Additional Information
Starting date: December 2003
Ending date: November 2004
Last updated: April 2, 2008
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