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

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VPI-2690B low dose
VPI-2690B medium dose
Placebo to match VPI-2690B
VPI-2690B high dose
Sponsored by
Vascular Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

VPI-2690B low dose

VPI-2690B medium dose

Placebo

VPI-2690B high dose

Arm Description

6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks

18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks

6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks

48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks

Outcomes

Primary Outcome Measures

Change from baseline in albuminuria

Secondary Outcome Measures

Change from baseline in eGFR

Full Information

First Posted
September 24, 2014
Last Updated
March 27, 2017
Sponsor
Vascular Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02251067
Brief Title
Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VPI-2690B low dose
Arm Type
Active Comparator
Arm Description
6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
Arm Title
VPI-2690B medium dose
Arm Type
Active Comparator
Arm Description
18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks
Arm Title
VPI-2690B high dose
Arm Type
Active Comparator
Arm Description
48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
Intervention Type
Drug
Intervention Name(s)
VPI-2690B low dose
Intervention Description
Comparison of different doses of study drug
Intervention Type
Drug
Intervention Name(s)
VPI-2690B medium dose
Intervention Description
Comparison of different doses of study drug
Intervention Type
Drug
Intervention Name(s)
Placebo to match VPI-2690B
Intervention Type
Drug
Intervention Name(s)
VPI-2690B high dose
Intervention Description
Comparison of different doses of study drug
Primary Outcome Measure Information:
Title
Change from baseline in albuminuria
Time Frame
50 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in eGFR
Time Frame
50 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vascular Pharmaceuticals Inc Clinical Trial
Organizational Affiliation
Vascular Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
La Mesa
State/Province
California
Country
United States
City
Riverside
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
Tustin
State/Province
California
Country
United States
City
Cooper City
State/Province
Florida
Country
United States
City
Coral Springs
State/Province
Florida
Country
United States
City
Hialeah
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
St. Petersburg
State/Province
Florida
Country
United States
City
Winter Park
State/Province
Florida
Country
United States
City
Columbus
State/Province
Georgia
Country
United States
City
Idaho Falls
State/Province
Idaho
Country
United States
City
Mt. Prospect
State/Province
Illinois
Country
United States
City
Peoria
State/Province
Illinois
Country
United States
City
Merrillville
State/Province
Indiana
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Flint
State/Province
Michigan
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Albany
State/Province
New York
Country
United States
City
Asheville
State/Province
North Carolina
Country
United States
City
Greenville
State/Province
North Carolina
Country
United States
City
Morehead City
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Wooster
State/Province
Ohio
Country
United States
City
Allentown
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
El Paso
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Ponce
Country
Puerto Rico
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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