Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients
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
1 other identifier
interventional
165
2 countries
34
Brief Summary
The purpose of this study is to determine whether VPI-2690B Injection is effective in the treatment of diabetic nephropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2014
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 24, 2014
CompletedFirst Posted
Study publicly available on registry
September 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 28, 2017
March 1, 2017
2.5 years
September 24, 2014
March 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in albuminuria
50 weeks
Secondary Outcomes (1)
Change from baseline in eGFR
50 weeks
Study Arms (4)
VPI-2690B low dose
ACTIVE COMPARATOR6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
VPI-2690B medium dose
ACTIVE COMPARATOR18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
Placebo
PLACEBO COMPARATOR6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks
VPI-2690B high dose
ACTIVE COMPARATOR48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
La Mesa, California, United States
Unknown Facility
Riverside, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Tustin, California, United States
Unknown Facility
Cooper City, Florida, United States
Unknown Facility
Coral Springs, Florida, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Winter Park, Florida, United States
Unknown Facility
Columbus, Georgia, United States
Unknown Facility
Idaho Falls, Idaho, United States
Unknown Facility
Mount Prospect, Illinois, United States
Unknown Facility
Peoria, Illinois, United States
Unknown Facility
Merrillville, Indiana, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Flint, Michigan, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Albany, New York, United States
Unknown Facility
Asheville, North Carolina, United States
Unknown Facility
Greenville, North Carolina, United States
Unknown Facility
Morehead City, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Wooster, Ohio, United States
Unknown Facility
Allentown, Pennsylvania, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
El Paso, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Ponce, Puerto Rico
Unknown Facility
San Juan, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Vascular Pharmaceuticals Inc Clinical Trial
Vascular Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2014
First Posted
September 26, 2014
Study Start
September 1, 2014
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
March 28, 2017
Record last verified: 2017-03