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

This study is currently recruiting participants.
Verified January 2013 by ChemoCentryx
Sponsor:
Information provided by (Responsible Party):
ChemoCentryx
ClinicalTrials.gov Identifier:
NCT01447147
First received: October 4, 2011
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by ChemoCentryx:

Primary Outcome Measures:
  • Subject incidence of adverse events [ Time Frame: Up to 365 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: October 2011
Estimated Study Completion Date: September 2014
Estimated 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447147

Contacts
Contact: Antonia Potarca +31 6 30892290

  Show 55 Study Locations
Sponsors and Collaborators
ChemoCentryx
Investigators
Study Director: Pirow Bekker, MD, PhD ChemoCentryx
  More Information

No publications provided

Responsible Party: ChemoCentryx
ClinicalTrials.gov Identifier: NCT01447147     History of Changes
Other Study ID Numbers: CL005_140
Study First Received: October 4, 2011
Last Updated: January 11, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 23, 2013