Status:
COMPLETED
Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients
Lead Sponsor:
Vascular Pharmaceuticals, Inc.
Conditions:
Diabetic Nephropathy
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT02251067
Start Date
September 1 2014
End Date
March 1 2017
Last Update
March 28 2017
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States
2
Little Rock, Arkansas, United States
3
La Mesa, California, United States
4
Riverside, California, United States