A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria

Overview

The purpose of this study is to evaluate the effect of treatment with CCX140-B on urinary albumin excretion in subjects with type 2 diabetes mellitus and albuminuria, as well as to study the safety and efficacy of the medication in this patient population.

Full Title of Study: “A Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Effect of CCX140-B on Albuminuria in Subjects With Type 2 Diabetes Mellitus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: February 2013

Interventions

  • Drug: Placebo
    • Placebo capsules once daily
  • Drug: CCX140-B
    • CCX140-B capsules once daily (Group B)

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo (Group A)
  • Experimental: Active study medication (Group B)
    • CCX140-B

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in 24-hour urinary albumin excretion
    • Time Frame: 84 days
    • The primary efficacy objective of this study is to evaluate the effect of CCX140-B treatment on urinary albumin excretion by measuring change from baseline in 24-hour urinary albumin excretion.
  • Subject incidence of adverse events
    • Time Frame: 84 days
    • The primary safety objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with type 2 diabetes mellitus (T2DM) with albuminuria.

Secondary Measures

  • Change from baseline in hemoglobin A1c
    • Time Frame: 84 days

Participating in This Clinical Trial

Key Inclusion Criteria:

  • Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association [ADA] criteria), and treated with oral antidiabetic drugs – Albumin:creatinine ratio (ACR) of 200 to 3000 mg/g creatinine, inclusive, based on two values obtained from two first morning urine samples taken on two separate days during the screening period – Estimated glomerular filtration rate based on serum creatinine (eGFR, determined by Modification of Diet in Renal Disease [MDRD] equation) of ≥ 25 mL/min/1.73 m(2) – Must be on a stable dose of an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 8 weeks prior to screening – Fasting plasma glucose less than 270 mg/dL at screening Key Exclusion Criteria:

  • Type 1 diabetes mellitus or history of diabetic ketoacidosis – Previous renal transplant or known non-diabetic renal disease, except related to hypertension – Undergone renal dialysis at any time in the past – Received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening – Use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening – Received chronic (more than 7 days continuously) non-steroidal anti-inflammatory drug (NSAID) treatment within 2 weeks of screening – Cardiac failure (class III or IV), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening – Poorly-controlled blood pressure (systolic blood pressure >155 or diastolic blood pressure >95, with blood pressure measured in the seated position after at least 5 minutes of rest)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ChemoCentryx
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • MD, Study Director, Amgen

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