VPI-CLIN- 201-AD: 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
Principal Investigator: Amy Mottl, MD
Sponsor: Vascular Pharmaceuticals, Inc.
Age Range: Type 1: 21-80 years of age; Type 2: 30-80 years of age
Status: Enrollment closed for 2016 but will reopen in 2017
Purpose: The primary objective of this study is to evaluate the efficacy of 2 doses of VPI-2690B Injection, administered once every 2 weeks by subcutaneous injection, compared to placebo, as assessed by the percent change from baseline to endpoint in albuminuria (as measured by urinary albumin to creatinine ratio mg/g in first morning void urine samples) in patients with nephropathy due to diabetes. The secondary objectives of the study are comparisons of VPI-2690B Injection to placebo for efficacy and safety.
Study Procedures: There are two cohorts in this study. Cohort A is complete and no longer enrolling. An interim analysis is being performed on Cohort A. Cohort B will open to enrollment after the analysis of Cohort A is completed. Approximately 85-120 study patients will be enrolled in the VPI-290B Injection group and 85 placebo patients will be enrolled. The doses to be administered will be determined based on the Cohort A interim analysis. Subjects will be taught and are encouraged to give the injections at home.
Participation: Enrolled patients will complete a 48-week blinded Treatment Period, followed by 2 safety visits for a total of 18 study visits, for a maximum duration of approximately 62 weeks.
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