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

Phase 2

Terminated

• Conditions: Type 2 Diabetes Mellitus; Diabetic Nephropathy; Diabetic Kidney Disease
• Interventions: Drug: Placebo; Drug: FG-3019

• Registration Number: NCT00913393
• Lead Sponsor: FibroGen

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).

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2019-02
• Disposition First Submitted: 2019-02-20
• Disposition First Submitted QC: 2019-02-20
• Last Update Submitted: 2019-02-20
• Disposition First Posted: 2019-02-22
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo IV
2	FG-3019	3 mg/kg FG-3019 IV
3	FG-3019	10 mg/kg FG-3019 IV

Primary Outcome Measures

Name	Time	Method
Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo	6 months

Secondary Outcome Measures

Name	Time	Method
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