Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients
NCT ID: NCT02251067
Last Updated: 2017-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
165 participants
INTERVENTIONAL
2014-09-30
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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VPI-2690B low dose
6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
VPI-2690B low dose
Comparison of different doses of study drug
VPI-2690B medium dose
18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
VPI-2690B medium dose
Comparison of different doses of study drug
Placebo
6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks
Placebo to match VPI-2690B
VPI-2690B high dose
48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
VPI-2690B high dose
Comparison of different doses of study drug
Interventions
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VPI-2690B low dose
Comparison of different doses of study drug
VPI-2690B medium dose
Comparison of different doses of study drug
Placebo to match VPI-2690B
VPI-2690B high dose
Comparison of different doses of study drug
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
80 Years
ALL
No
Sponsors
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Vascular Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Vascular Pharmaceuticals Inc Clinical Trial
Role: STUDY_DIRECTOR
Vascular Pharmaceuticals, Inc.
Locations
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Birmingham, Alabama, United States
Little Rock, Arkansas, United States
La Mesa, California, United States
Riverside, California, United States
Sacramento, California, United States
Tustin, California, United States
Cooper City, Florida, United States
Coral Springs, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
St. Petersburg, Florida, United States
Winter Park, Florida, United States
Columbus, Georgia, United States
Idaho Falls, Idaho, United States
Mount Prospect, Illinois, United States
Peoria, Illinois, United States
Merrillville, Indiana, United States
Boston, Massachusetts, United States
Flint, Michigan, United States
Kansas City, Missouri, United States
Las Vegas, Nevada, United States
Albany, New York, United States
Asheville, North Carolina, United States
Greenville, North Carolina, United States
Morehead City, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Wooster, Ohio, United States
Allentown, Pennsylvania, United States
Nashville, Tennessee, United States
El Paso, Texas, United States
San Antonio, Texas, United States
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Countries
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Other Identifiers
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VPI-CLIN-201-AD
Identifier Type: -
Identifier Source: org_study_id
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