- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00456053
A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human Erythropoietin
November 2, 2007 updated by: FibroGen
The purpose of this study is to test the safety and efficacy of FG-2216 in the treatment of patients with renal anemia who are not receiving erythropoietin and who are not on dialysis.
Study Overview
Study Type
Interventional
Enrollment (Actual)
145
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States
- Research Site
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Arkansas
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Little Rock, Arkansas, United States
- Research Site
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California
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Los Angeles, California, United States
- 3 Research Sites
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Oakland, California, United States
- Research Site
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San Diego, California, United States
- Research Site
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Santa Clara, California, United States
- Research Site
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Florida
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Lauderdale Lakes, Florida, United States
- Research Site
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Miami, Florida, United States
- Research Site
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Pembroke Pines, Florida, United States
- Research Site
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Georgia
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Atlanta, Georgia, United States
- Research Site
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Illinois
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South Holland, Illinois, United States
- Research Site
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Louisiana
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Shreveport, Louisiana, United States
- Research Site
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Massachusetts
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Springfield, Massachusetts, United States
- Research Site
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Michigan
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Kalamazoo, Michigan, United States
- Research Site
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Pontiac, Michigan, United States
- Research Site
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New York
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Flushing, New York, United States
- Research Site
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Ohio
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Cincinnati, Ohio, United States
- Research Site
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Columbus, Ohio, United States
- Research Site
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Oregon
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Portland, Oregon, United States
- Research Site
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Pennsylvania
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Allentown, Pennsylvania, United States
- Research Site
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Hershey, Pennsylvania, United States
- Research Site
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Pittsburgh, Pennsylvania, United States
- Research Site
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South Carolina
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Orangeburg, South Carolina, United States
- Research Site
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Texas
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Houston, Texas, United States
- Research Site
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San Antonio, Texas, United States
- Research Site
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Virginia
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Chesapeake, Virginia, United States
- Research Site
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Fairfax, Virginia, United States
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Stage 3 or 4 chronic kidney disease
- appropriate hemoglobin levels
Exclusion Criteria:
- Neovascular age related macular degeneration requiring treatment
- Macular edema or proliferative retinopathy in diabetic subjects, requiring treatment
- Any history of malignancy
- Therapy with recombinant erythropoietin or red blood cell transfusion within 4 weeks
- Renal Transplant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Hemoglobin (Hb) response
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Secondary Outcome Measures
Outcome Measure |
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Safety
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Attainment of Hb target range (11-13)
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Duration of maintenance of Hb in target range (11-13)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
April 2, 2007
First Submitted That Met QC Criteria
April 2, 2007
First Posted (Estimate)
April 4, 2007
Study Record Updates
Last Update Posted (Estimate)
November 6, 2007
Last Update Submitted That Met QC Criteria
November 2, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FGCL-SM2216-019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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