Back to resultsStudy of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy
Primary Purpose
Type 2 Diabetes Mellitus, Diabetic Nephropathy, Diabetic Kidney Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FG-3019
FG-3019
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Key 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
Key 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Placebo IV
3 mg/kg FG-3019 IV
10 mg/kg FG-3019 IV
Outcomes
Primary Outcome Measures
Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo
Secondary Outcome Measures
Measure: Safety and tolerability of FG-3019 in the study population.
Measure: Change from baseline in eGFR for each FG-3019 arm compared to placebo
Measure: Change from baseline in serum creatinine for each FG-3019 arm compared with placebo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00913393
Brief Title
Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy
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 Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated early for business purposes and as a result of a strategic decision to shift focus to another indication.
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FibroGen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Diabetic Nephropathy, Diabetic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo IV
Arm Title
2
Arm Type
Experimental
Arm Description
3 mg/kg FG-3019 IV
Arm Title
3
Arm Type
Experimental
Arm Description
10 mg/kg FG-3019 IV
Intervention Type
Drug
Intervention Name(s)
FG-3019
Intervention Description
3 mg/kg FG-3019 IV every 2 weeks for 22 weeks
Intervention Type
Drug
Intervention Name(s)
FG-3019
Intervention Description
10 mg/kg FG-3019 IV every 2 weeks for 22 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo IV every 2 weeks for 22 weeks
Primary Outcome Measure Information:
Title
Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Measure: Safety and tolerability of FG-3019 in the study population.
Time Frame
12 months
Title
Measure: Change from baseline in eGFR for each FG-3019 arm compared to placebo
Time Frame
6 months
Title
Measure: Change from baseline in serum creatinine for each FG-3019 arm compared with placebo
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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
Key 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
Facility Information:
City
Tempe
State/Province
Arizona
Country
United States
City
Buena Park
State/Province
California
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United States
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Lakewood
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California
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United States
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Sacramento
State/Province
California
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United States
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Walnut Creek
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California
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United States
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Whittier
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California
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United States
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Atlanta
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Georgia
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United States
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Evergreen Park
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Illinois
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United States
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Topeka
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Kansas
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United States
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Wichita
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Kansas
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United States
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Kenner
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Louisiana
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United States
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Springfield
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Massachusetts
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United States
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Saint Clair Shores
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Michigan
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United States
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Lincoln
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Nebraska
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United States
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Omaha
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Nebraska
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United States
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Berlin
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New Jersey
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United States
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Buffalo
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New York
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United States
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Flushing
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New York
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United States
City
New York
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New York
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United States
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Greenville
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North Carolina
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United States
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Toledo
State/Province
Ohio
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United States
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Chattanooga
State/Province
Tennessee
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United States
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Knoxville
State/Province
Tennessee
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United States
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Dallas
State/Province
Texas
Country
United States
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Houston
State/Province
Texas
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United States
City
San Antonio
State/Province
Texas
Country
United States
City
Fairfax
State/Province
Virginia
Country
United States
City
Spokane
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy
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