Status:
COMPLETED
Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy
Lead Sponsor:
FibroGen
Conditions:
Diabetes Mellitus
Diabetic Nephropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of two dosing regimens of FG-3019 administered over 12 weeks in patients with diabetic nephropathy and proteinuria on background an...
Eligibility Criteria
Inclusion
- Age 18-80 years, inclusive
- Diagnosis of type 1 or type 2 diabetes according to American Diabetes Association (ADA) criteria
- First morning urinary ACR \>0.200 g/g
- Receiving stable doses of ACEi and/or ARB therapy prior to Screening
- Estimated glomerular filtration rate of ≥20 and \<90 mL/min/1.73 m2
- Willingness to maintain ACEi and/or ARB therapy, and any additional anti-hypertensive therapies to control blood pressure, at a stable dose
- Maintenance of all additional antihypertensive medications, insulin, oral hypoglycemic agents, and cholesterol-lowering medications prior to randomization
Exclusion
- Female subjects who are pregnant or breastfeeding
- Organ transplant recipient, previous dialysis, or non-diabetic renal disease other than benign cysts or anatomical variants
- Any history of New York Heart Association (NYHA) class III/IV heart failure (HF)
- Screening electrocardiogram showing acute, clinically significant findings including but not limited to ST depression
- Recent history of serious heart problems (e.g. coronary artery bypass graft, cerebrovascular accident, or myocardial infarction)
- History of cancer in the past 5 years, possibly excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer.
- History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
- Participation in other studies of investigational drugs at the time of Screening AND receipt of an investigational drug within 42 days prior to Screening
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 times the upper limit of normal
- Hemoglobin \<10 g/dL
- Positive for HIV (IgG) antibody
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00754143
Start Date
March 1 2008
End Date
December 1 2009
Last Update
August 2 2019
Active Locations (18)
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1
Birmingham, Alabama, United States
2
Tempe, Arizona, United States
3
La Mesa, California, United States
4
Torrance, California, United States