A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of treatment with CCX140-B on urinary albumin excretion in subjects with type 2 diabetes mellitus and albuminuria, as well as to study the safety and efficacy of the medication in this patient population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ChemoCentryx

Criteria

Key Inclusion Criteria:

• Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association [ADA] criteria), and treated with oral antidiabetic drugs

• 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

• 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 angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 8 weeks prior to screening

• 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)