Status:
TERMINATED
Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy
Lead Sponsor:
FibroGen
Conditions:
Type 2 Diabetes Mellitus
Diabetic Nephropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effect of FG-3019 on diabetic kidney disease or diabetic nephropathy.
Detailed Description
The primary objective of this study is to assess the effect of FG-3019 on proteinuria as assessed by urinary albumin/creatinine ratio (ACR).
Eligibility Criteria
Inclusion
- Key
- Signed written informed consent
- Males and females 18-75 years of age, inclusive
- Diagnosis of type 2 diabetes mellitus according to American Diabetes Association (ADA) criteria
- 24-hour urinary ACR 200-3000 mg/g, inclusive, on two occasions during screening at least 2 days apart
- Estimated glomerular filtration rate (eGFR) (by MDRD equation) \>20 mL/min/1.73 m2
- Mean systolic blood pressure less than or equal to 150 mmHg and a mean diastolic blood pressure less than or equal to 95 mmHg
- 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
- Key
Exclusion
- Females who are pregnant or breast feeding
- Organ transplant recipient, history of dialysis, or known non-diabetic renal disease other than benign cysts or anatomical variants
- History of New York Heart Association class III/IV heart failure
- Screening electrocardiogram showing acute and/or clinically significant findings including but not limited to ST depression
- 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
- History of anaphylactic or systemic allergic reaction to human, humanized, chimeric, or murine monoclonal antibodies
- 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
- Hemoglobin \<10 g/dL
- Hemoglobin A1c (HbA1c) \>9 %
- Low density lipoprotein (LDL) \>130 mg/dL
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00913393
Start Date
February 1 2009
End Date
June 1 2010
Last Update
February 22 2019
Active Locations (28)
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1
Tempe, Arizona, United States
2
Buena Park, California, United States
3
Lakewood, California, United States
4
Sacramento, California, United States