Clinical trial NCT00913393: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Diabetic Nephropathy
Diabetic Kidney Disease
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo
timeFrame: 6 months
Secondary outcomes:
measure: Measure: Safety and tolerability of FG-3019 in the study population.
timeFrame: 12 months
measure: Measure: Change from baseline in eGFR for each FG-3019 arm compared to placebo
timeFrame: 6 months
measure: Measure: Change from baseline in serum creatinine for each FG-3019 arm compared with placebo
timeFrame: 6 months
Other outcomes:
Locations:
city: Tempe
country: United States
state: Arizona
city: Buena Park
country: United States
state: California
city: Lakewood
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Whittier
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Evergreen Park
country: United States
state: Illinois
city: Topeka
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Kenner
country: United States
state: Louisiana
city: Springfield
country: United States
state: Massachusetts
city: Saint Clair Shores
country: United States
state: Michigan
city: Lincoln
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Berlin
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: New York
country: United States
state: New York
city: Greenville
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Chattanooga
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
Study officials:
References: