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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Trial Summary
Trial Overview
Inclusion Criteria

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
sites
Clinical Trial Facility in Miami Florida
Miami, Florida 33136
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Miami, FL
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Clinical Trial Facility in Albany New York
Albany, New York 12205
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Albany, NY
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Clinical Trial Facility in Allentown Pennsylvania
Allentown, Pennsylvania
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Allentown, PA
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Clinical Trial Facility in Asheville North Carolina
Asheville, North Carolina
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Asheville, NC
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Clinical Trial Facility in Birmingham Alabama
Birmingham, Alabama
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Birmingham, AL
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Clinical Trial Facility in Boston Massachusetts
Boston, Massachusetts
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Boston, MA
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Clinical Trial Facility in Cincinnati Ohio
Cincinnati, Ohio
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Cincinnati, OH
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Clinical Trial Facility in Columbus Georgia
Columbus, Georgia 31904
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Columbus, GA
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Clinical Trial Facility in Cooper City Florida
Cooper City, Florida
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Cooper City, FL
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Clinical Trial Facility in Coral Springs Florida
Coral Springs, Florida 33065
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Coral Springs, FL
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Clinical Trial Facility in El Paso Texas
El Paso, Texas 79902
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El Paso, TX
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Clinical Trial Facility in Flint Michigan
Flint, Michigan 48532
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Flint, MI
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Clinical Trial Facility in Greenville North Carolina
Greenville, North Carolina 27834
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Greenville, NC
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Clinical Trial Facility in Hialeah Florida
Hialeah, Florida
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Hialeah, FL
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Clinical Trial Facility in Idaho Falls Idaho
Idaho Falls, Idaho
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Idaho Falls, ID
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Clinical Trial Facility in Kansas City Missouri
Kansas City, Missouri 64108
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Kansas City, MO
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Clinical Trial Facility in La Mesa California
La Mesa, California 91942
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La Mesa, CA
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Clinical Trial Facility in Las Vegas Nevada
Las Vegas, Nevada 89135
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Las Vegas, NV
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Clinical Trial Facility in Little Rock Arkansas
Little Rock, Arkansas
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Little Rock, AR
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Clinical Trial Facility in Merrillville Indiana
Merrillville, Indiana
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Merrillville, IN
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Clinical Trial Facility in Morehead City North Carolina
Morehead City, North Carolina 28557
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Morehead City, NC
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Clinical Trial Facility in Mt. Prospect Illinois
Mt. Prospect, Illinois
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Mt. Prospect, IL
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Clinical Trial Facility in Nashville Tennessee
Nashville, Tennessee 37232
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Nashville, TN
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Clinical Trial Facility in Peoria Illinois
Peoria, Illinois 61603
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Peoria, IL
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Clinical Trial Facility in Ponce
Ponce, 00716
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Ponce,
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Clinical Trial Facility in Riverside California
Riverside, California 92505
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Riverside, CA
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Clinical Trial Facility in Sacramento California
Sacramento, California 95825
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Sacramento, CA
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Clinical Trial Facility in San Antonio Texas
San Antonio, Texas 78224
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San Antonio, TX
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Clinical Trial Facility in St. Petersburg Florida
St. Petersburg, Florida 33701
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St. Petersburg, FL
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Clinical Trial Facility in Tustin California
Tustin, California 92780
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Tustin, CA
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Clinical Trial Facility in Winston-Salem North Carolina
Winston-Salem, North Carolina
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Winston-Salem, NC
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Clinical Trial Facility in Winter Park Florida
Winter Park, Florida
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Winter Park, FL
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Clinical Trial Facility in Wooster Ohio
Wooster, Ohio 44691
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Wooster, OH
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