Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy
NCT ID: NCT00754143
Last Updated: 2019-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2008-03-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Placebo
FG-3019
Placebo every 2 weeks IV for all infusions
B
FG-3019 5 mg/kg
FG-3019
FG-3019 5 mg/kg every 2 weeks IV for all infusions
C
FG-3019 10 mg/kg
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
Interventions
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FG-3019
Placebo every 2 weeks IV for all infusions
FG-3019
FG-3019 5 mg/kg every 2 weeks IV for all infusions
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
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of type 1 or type 2 diabetes according to American Diabetes Association (ADA) criteria
3. First morning urinary ACR \>0.200 g/g
4. Receiving stable doses of ACEi and/or ARB therapy prior to Screening
5. Estimated glomerular filtration rate of ≥20 and \<90 mL/min/1.73 m2
6. Willingness to maintain ACEi and/or ARB therapy, and any additional anti-hypertensive therapies to control blood pressure, at a stable dose
7. Maintenance of all additional antihypertensive medications, insulin, oral hypoglycemic agents, and cholesterol-lowering medications prior to randomization
Exclusion Criteria
2. Organ transplant recipient, previous dialysis, or non-diabetic renal disease other than benign cysts or anatomical variants
3. Any history of New York Heart Association (NYHA) class III/IV heart failure (HF)
4. Screening electrocardiogram showing acute, clinically significant findings including but not limited to ST depression
5. Recent history of serious heart problems (e.g. coronary artery bypass graft, cerebrovascular accident, or myocardial infarction)
6. History of cancer in the past 5 years, possibly excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer.
7. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
8. Participation in other studies of investigational drugs at the time of Screening AND receipt of an investigational drug within 42 days prior to Screening
9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 times the upper limit of normal
10. Hemoglobin \<10 g/dL
11. Positive for HIV (IgG) antibody
18 Years
80 Years
ALL
No
Sponsors
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FibroGen
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Tempe, Arizona, United States
La Mesa, California, United States
Torrance, California, United States
Kissimmee, Florida, United States
Atlanta, Georgia, United States
Springfield, Massachusetts, United States
Omaha, Nebraska, United States
Flushing, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Hershey, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Fairfax, Virginia, United States
Countries
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Other Identifiers
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FGCL-3019-029
Identifier Type: -
Identifier Source: org_study_id
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