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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

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ClinicalTrials.gov Identifier: NCT02251067
Recruitment Status : Completed
First Posted : September 26, 2014
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: VPI-2690B low dose Drug: VPI-2690B medium dose Drug: Placebo to match VPI-2690B Drug: VPI-2690B high dose Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : September 2014
Primary Completion Date : March 2017
Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 medium dose
18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
Drug: VPI-2690B medium dose
Comparison of different doses of study drug
Placebo Comparator: Placebo
6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks
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
Drug: VPI-2690B high dose
Comparison of different doses of study drug


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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251067


  Show 34 Study Locations
Sponsors and Collaborators
Vascular Pharmaceuticals, Inc.
Investigators
Study Director: Vascular Pharmaceuticals Inc Clinical Trial Vascular Pharmaceuticals, Inc.
More Information

Responsible Party: Vascular Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02251067     History of Changes
Other Study ID Numbers: VPI-CLIN-201-AD
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases