Diabetic Nephropathy
Conditions
Brief summary
The purpose of this study is to determine whether VPI-2690B Injection is effective in the treatment of diabetic nephropathy.
Interventions
DRUGVPI-2690B low dose
Comparison of different doses of study drug
DRUGVPI-2690B medium dose
Comparison of different doses of study drug
DRUGPlacebo to match VPI-2690B
DRUGVPI-2690B high dose
Comparison of different doses of study drug
Sponsors
Vascular Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* documented diabetic nephropathy in patients with either Type 1 or Type 2 diabetics * HbA1c of 7.5-10.5% * eGFR 30-110 mL/min/1.73m2 * stable ACEi/ARB dose regimen * stable blood pressure * BMI less than or equal to 45 kg/m2
Exclusion criteria
* non-diabetic renal disease * history of solid organ or islet cell transplant * history of malignancy within previous 5 years * systemic immunosuppression therapy * clinically significant liver disease, hepatitis B or C or HIV * monoclonal antibody treatment within previous year * recent acute renal injury or major surgery * significant, recent body weight change * biopsy proven glomerular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in albuminuria | 50 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in eGFR | 50 weeks |
Countries
Puerto Rico, United States
Outcome results
None listed