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

Amgen

Status and phase: Completed; Phase 2

Conditions: Diabetic Nephropathy; Type 2 Diabetes Mellitus

Treatments: Drug: CCX140-B; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01440257

CL007_140

Details and patient eligibility

About

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.

Full description

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Placebo (Group A)

Placebo Comparator group

Treatment:

Drug: Placebo

Active study medication (Group B)

Experimental group

Description:

CCX140-B

Treatment:

Drug: CCX140-B