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

FibroGen

Status and phase: Terminated; Phase 2

Conditions: Diabetic Nephropathy; Type 2 Diabetes Mellitus; Diabetic Kidney Disease

Treatments: Drug: Placebo; Drug: FG-3019

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913393

FGCL-3019-032

Details and patient eligibility

About

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

Full 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).

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo IV

Treatment:

Drug: Placebo

2

Experimental group

Description:

3 mg/kg FG-3019 IV

Treatment:

Drug: FG-3019

Drug: FG-3019

3

Experimental group

Description:

10 mg/kg FG-3019 IV

Treatment:

Drug: FG-3019

Drug: FG-3019