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

March 27, 2017 updated by: Vascular Pharmaceuticals, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico
      • San Juan, Puerto Rico
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • La Mesa, California, United States
      • Riverside, California, United States
      • Sacramento, California, United States
      • Tustin, California, 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
    • Georgia
      • Columbus, Georgia, United States
    • Idaho
      • Idaho Falls, Idaho, United States
    • Illinois
      • Mt. Prospect, Illinois, United States
      • Peoria, Illinois, United States
    • Indiana
      • Merrillville, Indiana, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Flint, Michigan, United States
    • Missouri
      • Kansas City, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New York
      • Albany, New York, 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
    • Ohio
      • Cincinnati, Ohio, United States
      • Wooster, Ohio, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • El Paso, Texas, United States
      • San Antonio, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in albuminuria
Time Frame: 50 weeks
50 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in eGFR
Time Frame: 50 weeks
50 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vascular Pharmaceuticals, Inc.

Investigators

  • Study Director: Vascular Pharmaceuticals Inc Clinical Trial, Vascular Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VPI-CLIN-201-AD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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