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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vascular Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02251067
First received: September 24, 2014
Last updated: March 27, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to determine whether VPI-2690B Injection is effective in the treatment of diabetic nephropathy.

Condition Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Vascular Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change from baseline in albuminuria [ Time Frame: 50 weeks ]

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

Enrollment: 165
Study Start Date: September 2014
Study Completion Date: March 2017
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
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 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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 24, 2014
Last Updated: March 27, 2017

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

ClinicalTrials.gov processed this record on July 28, 2017