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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00913393
Recruitment Status : Terminated (Study was terminated early for business purposes and as a result of a strategic decision to shift focus to another indication.)
First Posted : June 4, 2009
Last Update Posted : February 22, 2019
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Diabetic Nephropathy Diabetic Kidney Disease Drug: FG-3019 Drug: Placebo Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Placebo Comparator: 1
Placebo IV
Drug: Placebo
Placebo IV every 2 weeks for 22 weeks

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

Experimental: 3
10 mg/kg FG-3019 IV
Drug: FG-3019
10 mg/kg FG-3019 IV every 2 weeks for 22 weeks

Primary Outcome Measures :
  1. Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Measure: Safety and tolerability of FG-3019 in the study population. [ Time Frame: 12 months ]
  2. Measure: Change from baseline in eGFR for each FG-3019 arm compared to placebo [ Time Frame: 6 months ]
  3. Measure: Change from baseline in serum creatinine for each FG-3019 arm compared with placebo [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00913393

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United States, Arizona
Tempe, Arizona, United States
United States, California
Buena Park, California, United States
Lakewood, California, United States
Sacramento, California, United States
Walnut Creek, California, United States
Whittier, California, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Evergreen Park, Illinois, United States
United States, Kansas
Topeka, Kansas, United States
Wichita, Kansas, United States
United States, Louisiana
Kenner, Louisiana, United States
United States, Massachusetts
Springfield, Massachusetts, United States
United States, Michigan
Saint Clair Shores, Michigan, United States
United States, Nebraska
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
United States, New Jersey
Berlin, New Jersey, United States
United States, New York
Buffalo, New York, United States
Flushing, New York, United States
New York, New York, United States
United States, North Carolina
Greenville, North Carolina, United States
United States, Ohio
Toledo, Ohio, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Fairfax, Virginia, United States
United States, Washington
Spokane, Washington, United States
Sponsors and Collaborators
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Responsible Party: FibroGen Identifier: NCT00913393    
Other Study ID Numbers: FGCL-3019-032
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs