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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ChemoCentryx
ClinicalTrials.gov Identifier:
NCT01440257
First received: September 22, 2011
Last updated: July 19, 2013
Last verified: July 2013

September 22, 2011
July 19, 2013
September 2011
February 2013   (final data collection date for primary outcome measure)
  • Change from baseline in 24-hour urinary albumin excretion [ Time Frame: 84 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.
Same as current
Complete list of historical versions of study NCT01440257 on ClinicalTrials.gov Archive Site
Change from baseline in hemoglobin A1c [ Time Frame: 84 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria
A Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Effect of CCX140-B on Albuminuria in Subjects With Type 2 Diabetes Mellitus

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Diabetic Nephropathy
  • Type 2 Diabetes Mellitus
  • Drug: Placebo
    Placebo capsules once daily
  • Drug: CCX140-B
    CCX140-B capsules once daily (Group B)
  • Placebo Comparator: Placebo (Group A)
    Intervention: Drug: Placebo
  • Experimental: Active study medication (Group B)
    CCX140-B
    Intervention: Drug: CCX140-B
Sullivan T, Miao Z, Dairaghi DJ, Krasinski A, Wang Y, Zhao BN, Baumgart T, Ertl LS, Pennell A, Seitz L, Powers J, Zhao R, Ungashe S, Wei Z, Boring L, Tsou CL, Charo I, Berahovich RD, Schall TJ, Jaen JC. CCR2 antagonist CCX140-B provides renal and glycemic benefits in diabetic transgenic human CCR2 knockin mice. Am J Physiol Renal Physiol. 2013 Nov 1;305(9):F1288-97. doi: 10.1152/ajprenal.00316.2013. Epub 2013 Aug 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
September 2013
February 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01440257
CL007_140
No
ChemoCentryx
ChemoCentryx
Not Provided
Study Director: Pirow Bekker, MD, PhD ChemoCentryx, Inc.
ChemoCentryx
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP