A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy

Amgen

Status and phase

Completed

Phase 2

Conditions

Diabetic Nephropathy

Type 2 Diabetes Mellitus

Treatments

Drug: Placebo

Drug: CCX140-B

Study type

Interventional

Funder types

Industry

Identifiers

NCT01447147

CL005_140

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B in subjects with diabetic nephropathy.

Full description

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.

Enrollment

332 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)
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)