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Sponsored by: |
FibroGen |
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Information provided by: | FibroGen |
ClinicalTrials.gov Identifier: | NCT00754143 |
The purpose of this study is to evaluate the safety and tolerability of two dosing regimens of FG-3019 administered over 12 weeks in patients with diabetic nephropathy and proteinuria on background angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin II receptor antagonist (ARB) therapy.
Condition | Intervention | Phase |
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Diabetes Mellitus Diabetic Nephropathy |
Drug: FG-3019 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study of Safety, Pharmacokinetics and Pharmacodynamics of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy on Background ACEi and/or ARB Therapy |
Estimated Enrollment: | 36 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Placebo Comparator
Placebo
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Drug: FG-3019
Placebo every 2 weeks IV for all infusions
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B: Experimental
FG-3019 5 mg/kg
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Drug: FG-3019
FG-3019 5 mg/kg every 2 weeks IV for all infusions
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C: Experimental
FG-3019 10 mg/kg
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Drug: FG-3019
FG-3019 10 mg/kg IV for infusions on Days 1, 15, 29 and 57 and Placebo IV on Days 43 and 71
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sandy Liaw | (650) 866-7248 | sliaw@fibrogen.com |
United States, Alabama | |
Recruiting | |
Birmingham, Alabama, United States | |
United States, Arizona | |
Recruiting | |
Tempe, Arizona, United States | |
United States, California | |
Recruiting | |
La Mesa, California, United States | |
Recruiting | |
Torrance, California, United States | |
United States, Florida | |
Recruiting | |
Kissimmee, Florida, United States | |
United States, Georgia | |
Recruiting | |
Atlanta, Georgia, United States | |
United States, Massachusetts | |
Recruiting | |
Springfield, Massachusetts, United States | |
United States, Nebraska | |
Recruiting | |
Omaha, Nebraska, United States | |
United States, New York | |
Recruiting | |
Flushing Queens, New York, United States | |
Recruiting | |
New York, New York, United States | |
United States, North Carolina | |
Recruiting | |
Chapel Hill, North Carolina, United States | |
United States, Ohio | |
Recruiting | |
Cleveland, Ohio, United States | |
United States, Pennsylvania | |
Recruiting | |
Hershey, Pennsylvania, United States | |
United States, Texas | |
Recruiting | |
Houston, Texas, United States | |
Recruiting | |
San Antonio, Texas, United States | |
Recruiting | |
Dallas, Texas, United States | |
United States, Virginia | |
Recruiting | |
Fairfax, Virginia, United States |
Responsible Party: | FibroGen, Inc. ( Sandy Liaw, Senior Clinical Program Manager ) |
Study ID Numbers: | FGCL-3019-029 |
Study First Received: | September 15, 2008 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00754143 |
Health Authority: | United States: Food and Drug Administration |
Type 1 or Type 2 diabetes proteinuria |
Proteinuria Metabolic Diseases Diabetic Nephropathies Urologic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Kidney Diseases Metabolic disorder Glucose Metabolism Disorders Diabetes Complications |