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ISRCTN
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ISRCTN81307356
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ClinicalTrials.gov identifier
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NCT01440257
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Public title
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Study to evaluate the effect of CCX140-B on albuminuria in subjects with type 2 diabetes mellitus
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Scientific title
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A randomized, double-blind, placebo-controlled phase 2 study to evaluate the effect of CCX140-B on albuminuria in subjects with type 2 diabetes mellitus
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Acronym
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N/A
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Serial number at source
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CL007_140
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Study hypothesis
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The rationale for this study is to investigate whether CCX140-B treatment of subjects with type 2 diabetes mellitus (T2DM) and albuminuria can reduce albuminuria. Because CCX140-B blocks the monocyte / macrophage migration from blood to tissues that occurs only during inflammation, it is anticipated that administration of CCX140-B will provide selective therapeutic benefit without compromising general immune surveillance.
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Lay summary
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Lay summary under review
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Ethics approval
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Leiden University Medical Center Medical Ethics Committee, Leiden, Netherlands approved on 29 August 2011, ref: CHDR 1112
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Study design
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Randomized double-blind placebo-controlled single-center phase 2a study
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Type 2 Diabetes Mellitus with albuminuria
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Participants - inclusion criteria
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1. Male or female, aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association [ADA] criteria)
2. 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
3. Estimated glomerular filtration rate based on serum creatinine (eGFR), determined by Modification of Diet in Renal Disease [MDRD] equation of greater than or equal to 25 mL/min/1.73 m2
4. 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
5. Fasting plasma glucose less than 270 mg/dL at screening
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Participants - exclusion criteria
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1. Type 1 diabetes mellitus or history of diabetic ketoacidosis
2. Previous renal transplant or known non-diabetic renal disease, except related to hypertension
3. Has undergone renal dialysis at any time in the past
4. Received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening
5. Use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening
6. Received chronic (more than 7 days continuously) non-steroidal anti-inflammatory (NSAID) treatment within 2 weeks of screening
7. Cardiac failure (class III or IV), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening
8. 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)
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Anticipated start date
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01/09/2011
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Anticipated end date
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30/06/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet.
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Target number of participants
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Approximately 20
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Interventions
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Treatment: Four CCX140-B 2.5 mg capsules once daily for 84 days
Control: Four Placebo capsules once daily for 84 days
Following the 84-day dosing period, there will be a 28-day follow-up period
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Primary outcome measure(s)
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1. Change from baseline in 24-hour urinary albumin excretion over 84 days
2. Subject incidence of adverse events over 84 days
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Secondary outcome measure(s)
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Change in baseline of hemoglobin A1c over 84 days
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Sources of funding
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ChemoCentryx, Inc. (USA)
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Trial website
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Publications
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Contact name
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Dr
Koos
Burggraaf
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Address
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Centre for Human Drug Research
Zernikedreef 10
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City/town
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Leiden
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Zip/Postcode
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2333 CL
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Country
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Netherlands
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Email
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kb@chdr.nl
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Sponsor
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ChemoCentryx, Inc. (USA)
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Address
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850 Maude Avenue
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City/town
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Mountain View, CA
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Zip/Postcode
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94043
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Country
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United States of America
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Sponsor website:
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http://www.ChemoCentryx.com
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Date applied
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27/10/2011
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Last edited
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02/12/2011
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Date ISRCTN assigned
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02/12/2011
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