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ISRCTN
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ISRCTN77691094
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ClinicalTrials.gov identifier
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NCT01447147
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Public title
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Clinical trial to evaluate the safety and efficacy of CCX140-B in diabetic nephropathy
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Scientific title
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A randomized, double-blind, placebo-controlled, phase 2 study to evaluate the safety and efficacy of CCX140-B in diabetic nephropathy
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Acronym
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N/A
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Serial number at source
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CL005_140
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Study hypothesis
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The rationale for this phase 2 study is to determine whether CCX140-B is safe and well tolerated and shows evidence of renal or diabetic efficacy after oral administration of CCX140-B once daily for 84 consecutive days to subjects with diabetic nephropathy.
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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University Hospital Gent Commission on Medical Ethics, Gent, Belgium approved on 28 September 2011, Ref: 2011/502. All other centres will seek ethics approval before recruitment of the first participant.
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Study design
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Randomized double-blind placebo-controlled multi-center phase 2 study
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Countries of recruitment
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Belgium, Czech Republic, Germany, Hungary, Poland, United Kingdom
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Disease/condition/study domain
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Diabetic Nephropathy
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Participants - inclusion criteria
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1. Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (as per American Diabetes Association [ADA] criteria)
2. 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 200 to 3000 mg/g creatinine, inclusive)
3. Estimated glomerular filtration rate (eGFR) based on serum creatinine determined by Modification of Diet in Renal Disease [MDRD] equation of greater than or equal to 25 mL/min/1.73 m(2)
4. 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
5. Hemoglobin A1c (HbA1c) > 6.0% but not > 10.0% and 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. 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 drug (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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30/11/2011
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Anticipated end date
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31/08/2012
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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 135
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Interventions
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Group A: Four Placebo capsules once daily for 84 days. Following the 84-day dosing period, there will be a 28-day safety follow-up period.
Group B: Two 2.5 mg CCX140-B capsules and two placebo capsules once daily for 84 days. Following the 84-day dosing period, there will be a 28-day safety follow-up period.
Group C: Four 2.5 mg CCX140-B capsules once daily for 84 days
Following the 84-day dosing period, there will be a 28-day safety follow-up period.
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Primary outcome measure(s)
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To evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy
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Secondary outcome measure(s)
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Change from baseline in first morning urinary albumin:creatine ration (ACR)
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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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Mr
Daniel
Johnson
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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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Tel
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+1 650 210 2900
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Fax
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+1 650 210 2910
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Email
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djohnson@chemocentryx.com
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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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22/11/2011
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Last edited
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12/01/2012
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Date ISRCTN assigned
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12/01/2012
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