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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02251067
Recruitment Status : Completed
First Posted : September 26, 2014
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: VPI-2690B low dose Drug: VPI-2690B medium dose Drug: Placebo to match VPI-2690B Drug: VPI-2690B high dose Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: VPI-2690B low dose
6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
Drug: VPI-2690B low dose
Comparison of different doses of study drug

Active Comparator: VPI-2690B medium dose
18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
Drug: VPI-2690B medium dose
Comparison of different doses of study drug

Placebo Comparator: Placebo
6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks
Drug: Placebo to match VPI-2690B
Active Comparator: VPI-2690B high dose
48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
Drug: VPI-2690B high dose
Comparison of different doses of study drug




Primary Outcome Measures :
  1. Change from baseline in albuminuria [ Time Frame: 50 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in eGFR [ Time Frame: 50 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251067


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
La Mesa, California, United States
Riverside, California, United States
Sacramento, California, United States
Tustin, California, United States
United States, Florida
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
United States, Georgia
Columbus, Georgia, United States
United States, Idaho
Idaho Falls, Idaho, United States
United States, Illinois
Mt. Prospect, Illinois, United States
Peoria, Illinois, United States
United States, Indiana
Merrillville, Indiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Flint, Michigan, United States
United States, Missouri
Kansas City, Missouri, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
Albany, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
Greenville, North Carolina, United States
Morehead City, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Wooster, Ohio, United States
United States, Pennsylvania
Allentown, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
El Paso, Texas, United States
San Antonio, Texas, United States
Puerto Rico
Ponce, Puerto Rico
San Juan, Puerto Rico
Sponsors and Collaborators
Vascular Pharmaceuticals, Inc.
Investigators
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Study Director: Vascular Pharmaceuticals Inc Clinical Trial Vascular Pharmaceuticals, Inc.
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Responsible Party: Vascular Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02251067    
Other Study ID Numbers: VPI-CLIN-201-AD
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases