A randomized, double-blind, placebo-controlled, phase 2 study to evaluate the safety and efficacy of CCX140-B in diabetic nephropathy

ChemoCentryx, Inc. (USA)0 个研究点目标入组 135 人开始时间: 2012年1月12日最近更新: 2019年4月8日

适应症

试验速览

•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

•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)

发起方

ChemoCentryx, Inc. (USA)