Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients

Diabetic Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251067
• Other study ID #: VPI-CLIN-201-AD
• Status: Completed
• Phase: Phase 2
• First received: September 24, 2014
• Last updated: March 27, 2017
• Start date: September 2014
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Vascular Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• VPI-2690B low dose
Comparison of different doses of study drug
• VPI-2690B medium dose
Comparison of different doses of study drug
• Placebo to match VPI-2690B

• VPI-2690B high dose
Comparison of different doses of study drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in albuminuria		50 weeks
Secondary	Change from baseline in eGFR		50 weeks