Diabetic Kidney Disease, Diabetic Nephropathy, Type 2 Diabetes Mellitus
Conditions
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).
Interventions
DRUGFG-3019
3 mg/kg FG-3019 IV every 2 weeks for 22 weeks
DRUGPlacebo
Placebo IV every 2 weeks for 22 weeks
Sponsors
FibroGen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Signed written informed consent 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 Key
Exclusion criteria
1. Females who are pregnant or breast feeding 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Measure: Safety and tolerability of FG-3019 in the study population. | 12 months |
| Measure: Change from baseline in eGFR for each FG-3019 arm compared to placebo | 6 months |
| Measure: Change from baseline in serum creatinine for each FG-3019 arm compared with placebo | 6 months |
Countries
United States
Outcome results
None listed