Clinical trial NCT02251067: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Nephropathy
Lead sponsor: Vascular Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-26
Enrollment: 165
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change from baseline in albuminuria
timeFrame: 50 weeks
Secondary outcomes:
measure: Change from baseline in eGFR
timeFrame: 50 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: La Mesa
country: United States
state: California
city: Riverside
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Tustin
country: United States
state: California
city: Cooper City
country: United States
state: Florida
city: Coral Springs
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Mt. Prospect
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Merrillville
country: United States
state: Indiana
city: Boston
country: United States
state: Massachusetts
city: Flint
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Albany
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Morehead City
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Wooster
country: United States
state: Ohio
city: Allentown
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: El Paso
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Ponce
country: Puerto Rico
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Vascular Pharmaceuticals, Inc.
name: Vascular Pharmaceuticals Inc Clinical Trial
role: STUDY_DIRECTOR
References: