2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.
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.
1 other identifier
interventional
146
8 countries
43
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2003
Typical duration for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
September 28, 2009
CompletedJuly 8, 2013
May 1, 2013
11 months
September 13, 2005
August 19, 2009
May 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Baseline to 5 weeks and 9 weeks
Secondary Outcomes (4)
Change From Baseline in Hematocrit (Hct)
Baseline to 5 weeks and 9 weeks
Change From Baseline in Transferrin Saturation (TSAT).
Baseline to 5 weeks and 9 weeks
Change From Baseline in Serum Ferritin.
Baseline to 5 weeks and 9 weeks
Responders by Treatment Group
Baseline to 5 weeks and 9 weeks
Study Arms (3)
Sodium ferric gluconate complex 125 mg
EXPERIMENTAL125 mg sodium ferric gluconate weekly x 8 weeks
Sodium ferric gluconate complex 250 mg
EXPERIMENTAL250 mg sodium ferric gluconate complex weekly x 4 weeks
Oral iron
ACTIVE COMPARATOR325 mg ferrous sulfate three times daily x 8 weeks
Interventions
125 mg weekly x 8 weeks
Eligibility Criteria
You may qualify if:
- 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 predetermined low hemoglobin and transferrin saturation (TSAT) levels.
- Signed patient informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
Evanston, Illinois, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Royal Oak, Michigan, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Chapel Hill, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Sioux Falls, South Dakota, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Sofia, Bulgaria
Unknown Facility
Varna, Bulgaria
Unknown Facility
Kelowna, Canada
Unknown Facility
Kitchener, Canada
Unknown Facility
London, Canada
Unknown Facility
Scarborough, Canada
Unknown Facility
Toronto, Canada
Unknown Facility
Zagreb, Croatia
Unknown Facility
Bangalore, India
Unknown Facility
Chandigarh, India
Unknown Facility
Chennai, India
Unknown Facility
Hyderabad, India
Unknown Facility
Lucknow, India
Unknown Facility
Mahīm, India
Unknown Facility
New Delhi, India
Unknown Facility
Col. Toriello Guerra, Mexico
Unknown Facility
Durango, Mexico
Unknown Facility
Mexico City, Mexico
Unknown Facility
Monterrey, Mexico
Unknown Facility
Tlalpan, Mexico
Unknown Facility
Zapopan, Mexico
Unknown Facility
Osijek, Poland
Unknown Facility
Moscow, Russia
Unknown Facility
Saint Petersburg, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Primary endpoint for the 250 mg dose was 4 weeks earlier than the endpoint for the 125 mg dose, which may have contributed to lower Hbg increase with the 250 mg dose at endpoint.
Results Point of Contact
- Title
- Gary Hoel, RPh, PhD
- Organization
- Watson Laboratories, Inc
Study Officials
- STUDY CHAIR
Gary Hoel, RPh, PhD
Watson Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
December 1, 2003
Primary Completion
November 1, 2004
Study Completion
February 1, 2008
Last Updated
July 8, 2013
Results First Posted
September 28, 2009
Record last verified: 2013-05