Diabetes Mellitus, Diabetic Nephropathy
Conditions
Keywords
Type 1 or Type 2 diabetes, proteinuria
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 angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin II receptor antagonist (ARB) therapy.
Interventions
DRUGFG-3019
Placebo every 2 weeks IV for all infusions
Sponsors
Kyntra Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years, inclusive 2. Diagnosis of type 1 or type 2 diabetes according to American Diabetes Association (ADA) criteria 3. First morning urinary ACR \>0.200 g/g 4. Receiving stable doses of ACEi and/or ARB therapy prior to Screening 5. Estimated glomerular filtration rate of ≥20 and \<90 mL/min/1.73 m2 6. Willingness to maintain ACEi and/or ARB therapy, and any additional anti-hypertensive therapies to control blood pressure, at a stable dose 7. Maintenance of all additional antihypertensive medications, insulin, oral hypoglycemic agents, and cholesterol-lowering medications prior to randomization
Exclusion criteria
1. Female subjects who are pregnant or breastfeeding 2. Organ transplant recipient, previous dialysis, or non-diabetic renal disease other than benign cysts or anatomical variants 3. Any history of New York Heart Association (NYHA) class III/IV heart failure (HF) 4. Screening electrocardiogram showing acute, clinically significant findings including but not limited to ST depression 5. Recent history of serious heart problems (e.g. coronary artery bypass graft, cerebrovascular accident, or myocardial infarction) 6. History of cancer in the past 5 years, possibly excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer. 7. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies 8. Participation in other studies of investigational drugs at the time of Screening AND receipt of an investigational drug within 42 days prior to Screening 9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 times the upper limit of normal 10. Hemoglobin \<10 g/dL 11. Positive for HIV (IgG) antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of FG-3019 | 34 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters | 34 weeks |
| Change from baseline in first morning urinary albumin creatinine ratio (ACR) | 6 weeks (10 mg/kg) or 10 weeks (5 mg/kg) |
Countries
United States
Outcome results
None listed