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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ChemoCentryx
ClinicalTrials.gov Identifier:
NCT01447147
First received: October 4, 2011
Last updated: July 19, 2013
Last verified: July 2013

October 4, 2011
July 19, 2013
October 2011
August 2014   (final data collection date for primary outcome measure)
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.
Subject incidence of adverse events [ Time Frame: 84 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.
Complete list of historical versions of study NCT01447147 on ClinicalTrials.gov Archive Site
Change from baseline in first morning urinary albumin:creatinine ratio (ACR) [ Time Frame: Up to 365 days ] [ Designated as safety issue: No ]
Change from baseline in first morning urinary albumin:creatinine ratio (ACR) [ Time Frame: 84 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX140-B in Diabetic Nephropathy

The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B in subjects with diabetic nephropathy.

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.

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)
  • Drug: CCX140-B
    CCX140-B capsules once daily (Group C)
  • Placebo Comparator: Placebo (Group A)
    Intervention: Drug: Placebo
  • Experimental: CCX140-B (Group B)
    Intervention: Drug: CCX140-B
  • Experimental: CCX140-B (Group C)
    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
270
September 2014
August 2014   (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)
  • 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)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Germany,   Hungary,   Poland,   United Kingdom
 
NCT01447147
CL005_140
Yes
ChemoCentryx
ChemoCentryx
Not Provided
Study Director: Pirow Bekker, MD, PhD ChemoCentryx
ChemoCentryx
July 2013

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