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

Vascular Pharmaceuticals, Inc.165 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

165

Conditions

Diabetic Nephropathy

Interventions

VPI-2690B low doseDRUG

Comparison of different doses of study drug

VPI-2690B medium doseDRUG

Comparison of different doses of study drug

Placebo to match VPI-2690BDRUG

VPI-2690B high dose

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (34)

Unnamed facility

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Change from baseline in albuminuria

Time frame: 50 weeks

Secondary Outcomes

Change from baseline in eGFR

Time frame: 50 weeks

Data from ClinicalTrials.gov

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