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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00913393
• Other study ID #: FGCL-3019-032
• Status: Terminated
• Phase: Phase 2
• Start date: February 2009
• Est. completion date: June 2010

Study information

• Verified date: February 2019
• Source: FibroGen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Kidney Disease
• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
FibroGen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo		6 months
Secondary	Measure: Safety and tolerability of FG-3019 in the study population.		12 months
Secondary	Measure: Change from baseline in eGFR for each FG-3019 arm compared to placebo		6 months
Secondary	Measure: Change from baseline in serum creatinine for each FG-3019 arm compared with placebo		6 months