Title
Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group, Phase 2, Two-Part Adaptive Study to Evaluate the Safety and Efficacy of VPI-2690B Injection in Patients With Nephropathy Due to Diabetes
Phase
Phase 2Lead Sponsor
Vascular Pharmaceuticals, Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Diabetic NephropathyIntervention/Treatment
vpi-2690b ...Study Participants
165The purpose of this study is to determine whether VPI-2690B Injection is effective in the treatment of diabetic nephropathy.
Comparison of different doses of study drug
Comparison of different doses of study drug
Comparison of different doses of study drug
6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks
48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
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
