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

Phase 2

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: VPI-2690B high dose; Drug: VPI-2690B low dose; Drug: VPI-2690B medium dose; Drug: Placebo to match VPI-2690B

• Registration Number: NCT02251067
• Lead Sponsor: Vascular Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-24
• Study First Submitted QC: 2014-09-24
• Study First Posted: 2014-09-26
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VPI-2690B high dose	VPI-2690B high dose	48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
VPI-2690B low dose	VPI-2690B low dose	6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
VPI-2690B medium dose	VPI-2690B medium dose	18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
Placebo	Placebo to match VPI-2690B	6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in albuminuria	50 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in eGFR	50 weeks