Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition in Japan.

Inclusion Criteria

• Age equal to or above 20 years at the time of signing the Informed Consent Form
• Stage 3 to 5 non-dialysis-dependent chronic kidney disease (NDD-CKD), ie, estimated glomerular filtration rate above 10 and below 60 mL/min/1.73 m^2 using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) creatinine equation
• Serum hs-CRP level equal to or above 2.0 mg/L measured during the screening period. Note: Targeting patients with a history of advanced stage CKD, atherosclerotic cardiovascular disease, anemia, diabetic retinopathy, obesity, or elevated BMI, and diabetes for screening will help increase the chances of identifying patients with hs-CRP equal to or above2.0 mg/L 4. The patient agrees to comply with
• The patient agrees to comply with the contraception and reproduction restrictions of the study as follows:
• Women of childbearing potential must be using a method of contraception that is "highly effective" (ie, less than 1% failure rate) for at least 3 months following the last dose of study drug;
• Postmenopausal women must have had no menstrual bleeding for at least 1 year before initial dosing and either be over the age of 60 years or have an elevated plasma follicle stimulating hormone level (ie, above 40 mIU/mL) at screening;
• Women of childbearing potential must have a documented negative serum pregnancy test result at screening; and
• All male patients, from the day of dosing until the final study visit, unless surgically sterile, must be willing to use a condom with a partner (male patients with partners of childbearing potential must be willing to use 2 effective methods of birth control, 1 should be condom with spermicide) to prevent pregnancy and drug exposure of a partner, and refrain from donating sperm or fathering a child; and
• The patient must be willing and able to provide informed consent and abide all study requirements and restrictions.

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from participation in the study:

Laboratory values

• Absolute neutrophil count below 2.0 × 10^9/L during screening;
• Platelet count below 120 × 10^9/L during screening;
• Spot urine protein-creatinine ratio above 4000 mg/g (4.0 g/g) during screening;
• Alanine aminotransferase or aspartate aminotransferase above 2.5 × upper limit of normal during screening;
• Positive testing for tuberculosis during screening. blood testing (eg, QuantiFERON) is preferred, but a purified protein derivative (PPD) skin test read within 48 to 72 hours by a qualified healthcare professional may also be performed. If a patient is PPD positive but QuantiFERON negative, the patient is eligible;
• Evidence of human immunodeficiency virus (HIV)-1 or HIV-2 infection by serology measured during screening;
• Hepatitis B or C by serology (eg, hepatitis B surface antigen or hepatitis C antibody positive) measured during screening;

Medical conditions or diseases

• Expected to require blood transfusion within 12 weeks post-randomization;
• Thromboembolic event within 12 weeks prior to randomization;
• Clinical evidence or suspicion of active infection;
• History of peptic ulcer disease or gastrointestinal ulceration in the 12 months prior to randomization;
• History of active diverticulitis in the 12 months prior to randomization;
• History of inflammatory bowel disease that has been clinically active during the 12 months prior to randomization;
• Uncontrolled hypertension (defined as an average systolic blood pressure above 160 mmHg or an average diastolic blood pressure above 100 mmHg) during screening. Patients may be re-evaluated within 2 weeks, at the discretion of the Principal Investigator, for this criterion if antihypertensive therapy has been started or increased as a result of initial screening blood pressure being above these limits;
• Planned coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or any other major surg