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

NCT00913393 | Terminated Phase 2

• 1 other identifier: FGCL-3019-032
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 28

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus; Diabetic Nephropathy; Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (3)

• 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

Study Arms (3)

1

PLACEBO COMPARATOR

Placebo IV

Drug: Placebo

2

EXPERIMENTAL

3 mg/kg FG-3019 IV

Drug: FG-3019

3

EXPERIMENTAL

10 mg/kg FG-3019 IV

Drug: FG-3019

Interventions

FG-3019 DRUG

3 mg/kg FG-3019 IV every 2 weeks for 22 weeks

2

Placebo DRUG

Placebo IV every 2 weeks for 22 weeks

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyntra Bio: lead

Study Sites (28)

Unknown Facility

Tempe, Arizona, United States

Location

Unknown Facility

Buena Park, California, United States

Location

Unknown Facility

Lakewood, California, United States

Location

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

Walnut Creek, California, United States

Location

Unknown Facility

Whittier, California, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Evergreen Park, Illinois, United States

Location

Unknown Facility

Topeka, Kansas, United States

Location

Unknown Facility

Wichita, Kansas, United States

Location

Unknown Facility

Kenner, Louisiana, United States

Location

Unknown Facility

Springfield, Massachusetts, United States

Location

Unknown Facility

Saint Clair Shores, Michigan, United States

Location

Unknown Facility

Lincoln, Nebraska, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Berlin, New Jersey, United States

Location

Unknown Facility

Buffalo, New York, United States

Location

Unknown Facility

Flushing, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Greenville, North Carolina, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Chattanooga, Tennessee, United States

Location

Unknown Facility

Knoxville, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Fairfax, Virginia, United States

Location

Unknown Facility

Spokane, Washington, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies

Interventions

pamrevlumab

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 4, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

US (28)