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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02251067
Other study ID # VPI-CLIN-201-AD
Secondary ID
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
Health authority
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

Study Design


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
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