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Trial record 1 of 1 for:    vpi-2690b
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Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02251067
Recruitment Status : Completed
First Posted : September 26, 2014
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Vascular Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE September 24, 2014
First Posted Date  ICMJE September 26, 2014
Last Update Posted Date March 28, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2014)
Change from baseline in albuminuria [ Time Frame: 50 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2014)
Change from baseline in eGFR [ Time Frame: 50 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine whether VPI-2690B Injection is effective in the treatment of diabetic nephropathy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Nephropathy
Intervention  ICMJE
  • Drug: VPI-2690B low dose
    Comparison of different doses of study drug
  • Drug: VPI-2690B medium dose
    Comparison of different doses of study drug
  • Drug: Placebo to match VPI-2690B
  • Drug: VPI-2690B high dose
    Comparison of different doses of study drug
Study Arms  ICMJE
  • Active Comparator: VPI-2690B low dose
    6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
    Intervention: Drug: VPI-2690B low dose
  • Active Comparator: VPI-2690B medium dose
    18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
    Intervention: Drug: VPI-2690B medium dose
  • Placebo Comparator: Placebo
    6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks
    Intervention: Drug: Placebo to match VPI-2690B
  • Active Comparator: VPI-2690B high dose
    48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
    Intervention: Drug: VPI-2690B high dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2017)
165
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2014)
300
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02251067
Other Study ID Numbers  ICMJE VPI-CLIN-201-AD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Vascular Pharmaceuticals, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vascular Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Vascular Pharmaceuticals Inc Clinical Trial Vascular Pharmaceuticals, Inc.
PRS Account Vascular Pharmaceuticals, Inc.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP