Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of FG-3019 on diabetic kidney disease or diabetic nephropathy.

Detailed Description
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The primary objective of this study is to assess the effect of FG-3019 on proteinuria as assessed by urinary albumin/creatinine ratio (ACR).

Official Title
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A Phase 2 Randomized, Double-blind, Placebo-controlled Study of FG-3019 in Subjects With Type 2 Diabetes Mellitus (DM) and Persistent Proteinuria on Background Angiotensin Converting Enzyme Inhibitor (ACEi) and/or Angiotensin II Receptor Blockade (ARB) Therapy

Conditions
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Type 2 Diabetes Mellitus, Diabetic Nephropathy, Diabetic Kidney Disease

Intervention / Treatment
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* Drug: FG-3019
* Drug: FG-3019
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo IV | Drug: Placebo<br>* Placebo IV every 2 weeks for 22 weeks<br>|
| Experimental: 2<br>3 mg/kg FG-3019 IV | Drug: FG-3019<br>* 3 mg/kg FG-3019 IV every 2 weeks for 22 weeks<br>|
| Experimental: 3<br>10 mg/kg FG-3019 IV | Drug: FG-3019<br>* 10 mg/kg FG-3019 IV every 2 weeks for 22 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |