Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Diabetic Nephropathy

In brief

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 angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin II receptor antagonist (ARB) therapy.

Key facts

Study ID

NCT00754143

Run by

Kyntra Bio

People needed

38

Starts

2008-03-01

Expected to finish

2009-12-01

Last updated by the study team

2019-08-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Tempe, Arizona, United States
• Study site — La Mesa, California, United States
• Study site — Torrance, California, United States
• Study site — Kissimmee, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Omaha, Nebraska, United States
• Study site — Flushing, New York, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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