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.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

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)