Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients
| Status: | Completed |
|---|---|
| Conditions: | Diabetic Neuropathy, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 3/29/2017 |
| Start Date: | September 2014 |
| End Date: | March 2017 |
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.
treatment of diabetic nephropathy.
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
We found this trial at
33
sites
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