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

FibroGen0 sites46 target enrollmentFebruary 2009

ConditionsType 2 Diabetes Mellitus Diabetic Nephropathy Diabetic Kidney Disease

InterventionsPlacebo FG-3019

DrugsFG-3019 Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Type 2 Diabetes Mellitus
Sponsor: FibroGen
Enrollment: 46
Primary Endpoint: Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

June 2010

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

FibroGen

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

1

Placebo IV

Intervention: Placebo

2

3 mg/kg FG-3019 IV

Intervention: FG-3019

3

10 mg/kg FG-3019 IV

Intervention: FG-3019

Outcomes

Primary Outcomes

Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo

Time Frame: 6 months

Secondary Outcomes

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)