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A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01447147
First Posted: October 6, 2011
Last Update Posted: December 15, 2014
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.
Information provided by (Responsible Party):
ChemoCentryx
  Purpose
The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B in subjects with diabetic nephropathy.

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: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX140-B in Diabetic Nephropathy

Resource links provided by NLM:


Further study details as provided by ChemoCentryx:

Primary Outcome Measures:
  • Subject incidence of adverse events [ Time Frame: Up to 365 days ]
    The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy.


Secondary Outcome Measures:
  • Change from baseline in first morning urinary albumin:creatinine ratio (ACR) [ Time Frame: Up to 365 days ]

Enrollment: 332
Study Start Date: October 2011
Study Completion Date: December 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo (Group A) Drug: Placebo
Placebo capsules once daily
Experimental: CCX140-B (Group B) Drug: CCX140-B
CCX140-B capsules once daily (Group B)
Experimental: CCX140-B (Group C) Drug: CCX140-B
CCX140-B capsules once daily (Group C)

Detailed Description:

The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy based on subject incidence of adverse events.

The secondary objectives of this study include evaluation of the effect of CCX140-B on several measures of effectiveness commonly used in the evaluation of diabetes and renal medications.

  Eligibility

Information from the National Library of Medicine

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

Key Inclusion Criteria:

  • Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association [ADA] criteria)
  • Residual albuminuria despite stable treatment with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 8 weeks prior to screening (Albumin:creatinine ratio [ACR] of 100 to 3000 mg/g creatinine, inclusive)
  • 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 ACE inhibitor or ARB for at least 8 weeks prior to screening, but subjects must not be on both an ACE inhibitor and an ARB
  • Hemoglobin A1c (HbA1c) > 6.0% but not > 10.0% and 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
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): NCT01447147


  Show 83 Study Locations
Sponsors and Collaborators
ChemoCentryx
Investigators
Study Director: Pirow Bekker, MD, PhD ChemoCentryx
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ChemoCentryx
ClinicalTrials.gov Identifier: NCT01447147     History of Changes
Other Study ID Numbers: CL005_140
First Submitted: October 4, 2011
First Posted: October 6, 2011
Last Update Posted: December 15, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications