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

Vascular Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Diabetic Nephropathy

Treatments: Drug: VPI-2690B medium dose; Drug: Placebo to match VPI-2690B; Drug: VPI-2690B low dose; Drug: VPI-2690B high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02251067

VPI-CLIN-201-AD

Details and patient eligibility

About

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

Enrollment: 165 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

165 participants in 4 patient groups, including a placebo group

VPI-2690B low dose

Active Comparator group

Description:

6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks

Treatment:

Drug: VPI-2690B low dose

VPI-2690B medium dose

Active Comparator group

Description:

18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks

Treatment:

Drug: VPI-2690B medium dose

Placebo

Placebo Comparator group

Description:

6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks

Treatment:

Drug: Placebo to match VPI-2690B

VPI-2690B high dose

Active Comparator group

Description:

48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks

Treatment:

Drug: VPI-2690B high dose