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
1 other identifier
interventional
145
1 country
27
Brief Summary
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.
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 2005
27 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, 2005
CompletedFirst Submitted
Initial submission to the registry
April 2, 2007
CompletedFirst Posted
Study publicly available on registry
April 4, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedNovember 6, 2007
November 1, 2007
April 2, 2007
November 2, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin (Hb) response
Secondary Outcomes (3)
Attainment of Hb target range (11-13)
Duration of maintenance of Hb in target range (11-13)
Safety
Interventions
Eligibility Criteria
You may qualify if:
- Stage 3 or 4 chronic kidney disease
- appropriate hemoglobin levels
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyntra Biolead
Study Sites (27)
Research Site
Tucson, Arizona, United States
Research Site
Little Rock, Arkansas, United States
3 Research Sites
Los Angeles, California, United States
Research Site
Oakland, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Clara, California, United States
Research Site
Lauderdale Lakes, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Pembroke Pines, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
South Holland, Illinois, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Springfield, Massachusetts, United States
Research Site
Kalamazoo, Michigan, United States
Research Site
Pontiac, Michigan, United States
Research Site
Flushing, New York, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Allentown, Pennsylvania, United States
Research Site
Hershey, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Orangeburg, South Carolina, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Chesapeake, Virginia, United States
Research Site
Fairfax, Virginia, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 2, 2007
First Posted
April 4, 2007
Study Start
December 1, 2005
Study Completion
July 1, 2007
Last Updated
November 6, 2007
Record last verified: 2007-11