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



Status:Completed
Conditions:Diabetic Neuropathy, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:21 - 80
Updated:3/29/2017
Start Date:September 2014
End Date:March 2017

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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

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


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
We found this trial at
33
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Greenville, North Carolina 27834
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Morehead City, North Carolina 28557
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