Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephrop… (NCT00754143) | Clinical Trial Compass
CompletedPhase 1
Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy
United States38 participantsStarted 2008-03
Plain-language 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 angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin II receptor antagonist (ARB) therapy.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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