Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy
NCT ID: NCT00913393
Last Updated: 2019-02-22
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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TERMINATED
PHASE2
46 participants
INTERVENTIONAL
2009-02-28
2010-06-30
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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1
Placebo IV
Placebo
Placebo IV every 2 weeks for 22 weeks
2
3 mg/kg FG-3019 IV
FG-3019
3 mg/kg FG-3019 IV every 2 weeks for 22 weeks
3
10 mg/kg FG-3019 IV
FG-3019
10 mg/kg FG-3019 IV every 2 weeks for 22 weeks
Interventions
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FG-3019
3 mg/kg FG-3019 IV every 2 weeks for 22 weeks
FG-3019
10 mg/kg FG-3019 IV every 2 weeks for 22 weeks
Placebo
Placebo IV every 2 weeks for 22 weeks
Eligibility Criteria
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Inclusion Criteria
2. Males and females 18-75 years of age, inclusive
3. Diagnosis of type 2 diabetes mellitus according to American Diabetes Association (ADA) criteria
4. 24-hour urinary ACR 200-3000 mg/g, inclusive, on two occasions during screening at least 2 days apart
5. Estimated glomerular filtration rate (eGFR) (by MDRD equation) \>20 mL/min/1.73 m2
6. Mean systolic blood pressure less than or equal to 150 mmHg and a mean diastolic blood pressure less than or equal to 95 mmHg
7. Receiving ACEi and/or ARB therapy at an unchanged dose at or above the minimum trial dosage for at least 3 months prior to the first Screening visit and willing to maintain these doses throughout the treatment period
Exclusion Criteria
2. Organ transplant recipient, history of dialysis, or known non-diabetic renal disease other than benign cysts or anatomical variants
3. History of New York Heart Association class III/IV heart failure
4. Screening electrocardiogram showing acute and/or clinically significant findings including but not limited to ST depression
5. History of any of the following events within 3 months prior to Screening: coronary artery bypass graft, cerebrovascular accident, myocardial infarction, transient ischemic attack, unstable angina, uncontrolled cardiac arrhythmia, atrial fibrillation, percutaneous coronary intervention, or vascular stent placement
6. History of anaphylactic or systemic allergic reaction to human, humanized, chimeric, or murine monoclonal antibodies
7. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5 times the upper limit of normal; direct bilirubin above the upper limit of normal, or \>2.5 times the upper limit of normal in cases of documented Gilbert's syndrome
8. Hemoglobin \<10 g/dL
9. Hemoglobin A1c (HbA1c) \>9 %
10. Low density lipoprotein (LDL) \>130 mg/dL
18 Years
75 Years
ALL
No
Sponsors
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FibroGen
INDUSTRY
Responsible Party
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Locations
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Tempe, Arizona, United States
Buena Park, California, United States
Lakewood, California, United States
Sacramento, California, United States
Walnut Creek, California, United States
Whittier, California, United States
Atlanta, Georgia, United States
Evergreen Park, Illinois, United States
Topeka, Kansas, United States
Wichita, Kansas, United States
Kenner, Louisiana, United States
Springfield, Massachusetts, United States
Saint Clair Shores, Michigan, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Berlin, New Jersey, United States
Buffalo, New York, United States
Flushing, New York, United States
New York, New York, United States
Greenville, North Carolina, United States
Toledo, Ohio, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Fairfax, Virginia, United States
Spokane, Washington, United States
Countries
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Other Identifiers
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FGCL-3019-032
Identifier Type: -
Identifier Source: org_study_id
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