Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether VPI-2690B Injection is effective in the treatment of diabetic nephropathy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vascular Pharmaceuticals, Inc.

Criteria

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