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History of Changes for Study: NCT02251067
Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients
Latest version (submitted March 27, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 24, 2014 None (earliest Version on record)
2 October 9, 2014 Study Status and Contacts/Locations
3 November 23, 2014 Study Status and Contacts/Locations
4 May 19, 2015 Contacts/Locations and Study Status
5 December 9, 2015 Arms and Interventions and Study Status
6 December 18, 2015 Arms and Interventions, Study Status and Contacts/Locations
7 January 21, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 March 27, 2017 Recruitment Status and Study Status
Comparison Format:

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Study NCT02251067
Submitted Date:  September 24, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: VPI-CLIN-201-AD
Brief Title: Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients
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
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2014
Overall Status: Recruiting
Study Start: September 2014
Primary Completion: August 2017 [Anticipated]
Study Completion: August 2017 [Anticipated]
First Submitted: September 24, 2014
First Submitted that
Met QC Criteria:
September 24, 2014
First Posted: September 26, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 24, 2014
Last Update Posted: September 26, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Vascular Pharmaceuticals, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this study is to determine whether VPI-2690B Injection is effective in the treatment of diabetic nephropathy.
Detailed Description:
Open or close this module Conditions
Conditions: Diabetic Nephropathy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: VPI-2690B low dose
6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
Drug: VPI-2690B low dose
Comparison of different doses of study drug
Active Comparator: VPI-2690B high dose
18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
Drug: VPI-2690B high dose
Comparison of different doses of study drug
Placebo Comparator: Placebo
6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change from baseline in albuminuria
[ Time Frame: 50 weeks ]

Secondary Outcome Measures:
1. Change from baseline in eGFR
[ Time Frame: 50 weeks ]

Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Gerald Garrett
Telephone: 210.745.0940
Email: ggarrett@ind2results.com
Study Officials: Vascular Pharmaceuticals Inc Clinical Trial
Study Director
Vascular Pharmaceuticals, Inc.
Locations: United States, California
[Recruiting]
Tustin, California, United States
United States, North Carolina
[Recruiting]
Morehead City, North Carolina, United States
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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