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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447147

  Hide Study Locations
Locations
Belgium
Antwerp, Belgium
Brussels, Belgium
Edegem, Belgium
Ghent, Belgium
Leuven, Belgium
Liege, Belgium
Roeselare, Belgium
Czech Republic
Beroun, Czech Republic
Brno, Czech Republic
Hlucin, Czech Republic
Neratovice, Czech Republic
Novy Jicin, Czech Republic
NZdar nad Sazavou, Czech Republic
Pardubice, Czech Republic
Prague, Czech Republic
Prelouc, Czech Republic
Rakovnik, Czech Republic
Slany, Czech Republic
Trebic, Czech Republic
Uhersky Brod, Czech Republic
Unicov, Czech Republic
Germany
Berlin, Germany
Bosenheim, Germany
Deggingen, Germany
Dresden, Germany
Erlangen, Germany
Hannover, Germany
Heidelberg, Germany
Heilbronn, Germany
Hoyerswerda, Germany
Koeln, Germany
Munich, Germany
Neuwied, Germany
Nuernberg, Germany
Pirna, Germany
Potsdam, Germany
Saarlouis, Germany
Speyer, Germany
Wiesbaden, Germany
Hungary
Baja, Hungary
Balatonfuered, Hungary
Bekescsaba, Hungary
Budapest, Hungary
Debrecen, Hungary
Eger, Hungary
Gyula, Hungary
Hatvan, Hungary
Kaposvar, Hungary
Kisvarda, Hungary
Satoraljaujhely, Hungary
Szekszard, Tolna, Hungary
Szikszo, Hungary
Poland
Bialystok, Poland
Ciechanow, Poland
Gdansk, Poland
Grodzisk Mazowiecki, Poland
Krakow, Poland
Poznan, Poland
Radom, Poland
Rzeszow, Poland
Szczecin, Poland
Warsaw, Poland
Wroclaw, Poland
United Kingdom
Bath, United Kingdom
Belfast, United Kingdom
Birmingham, United Kingdom
Bristol, United Kingdom
Chester, United Kingdom
Coventry, United Kingdom
Doncaster, United Kingdom
Edmonton, United Kingdom
Liverpool, United Kingdom
Livingston, United Kingdom
London, United Kingdom
Londonderry, United Kingdom
Manchester, United Kingdom
Middlesbrough, United Kingdom
Norfolk, United Kingdom
Preston, United Kingdom
Salford, United Kingdom
Sheffield, United Kingdom
Swansea, United Kingdom
Welwyn Garden City, United Kingdom
Sponsors and Collaborators
ChemoCentryx
Investigators
Study Director: Pirow Bekker, MD, PhD ChemoCentryx
  More Information

No publications provided by ChemoCentryx

Additional 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
Study First Received: October 4, 2011
Last Updated: July 19, 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
Kidney Diseases
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on September 29, 2014