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

This study has been completed.
Information provided by (Responsible Party):
ChemoCentryx Identifier:
First received: September 22, 2011
Last updated: January 8, 2015
Last verified: January 2015
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.

Condition Intervention Phase
Diabetic Nephropathy
Type 2 Diabetes Mellitus
Drug: Placebo
Drug: CCX140-B
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Effect of CCX140-B on Albuminuria in Subjects With Type 2 Diabetes Mellitus

Further study details as provided by ChemoCentryx:

Primary Outcome 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 Outcome Measures:
  • Change from baseline in hemoglobin A1c [ Time Frame: 84 days ]

Enrollment: 20
Study Start Date: September 2011
Study Completion Date: September 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo (Group A) Drug: Placebo
Placebo capsules once daily
Experimental: Active study medication (Group B)
Drug: CCX140-B
CCX140-B capsules once daily (Group B)


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01440257

Centre for Human Drug Research
Leiden, Netherlands
Sponsors and Collaborators
Study Director: Pirow Bekker, MD, PhD ChemoCentryx, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ChemoCentryx Identifier: NCT01440257     History of Changes
Other Study ID Numbers: CL007_140
Study First Received: September 22, 2011
Last Updated: January 8, 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Diabetes Complications
Urination Disorders
Urological Manifestations
Signs and Symptoms processed this record on May 22, 2017