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

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 surgical procedure during the time frame of the study;
• •Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure within the past 6 months prior to randomization;
• •Prior gastric bypass surgery;
• •History of New York Heart Association (NYHA) Class IV congestive heart failure within 12 weeks prior to randomization;
• •Diagnosis of malignancy within 1 year prior to randomization with the exception of successfully treated nonmetastatic basal cell or squamous cell carcinomas of the skin and/or local carcinoma in situ of the cervix;
• •History of bone marrow or solid organ transplant or anticipated to receive an organ transplant during the time frame of the study;
• •Known allergy to the study drug or any of its ingredients;
• •Prior or current medications
• •Received an investigational drug within 30 days prior to screening;
• •Received a live vaccine product within 14 days of study drug administration or expect to receive live vaccine during the treatment period;
• •Expected to receive any investigational drug or any of the exclusionary drugs during the treatment period or safety follow-Up period;
• •Chronic use of systemic immunosuppressive drugs during the screening period or anticipated use of such drugs any time during the study. Note: Use of otic, ophthalmic, inhaled, and topical corticosteroids or local corticosteroid injections are not exclusionary. Oral prednisone up to 5 mg per day (or equivalent) is permitted if the dose has been stable for at least 4 weeks prior to Screening and no dose changes are planned during study participation. Short-term use of oral steroids for treatment of rash or asthma exacerbation is allowed;
• •Use of systemic antibiotics, systemic antivirals, or systemic antifungals during the screening period. Note: "Systemic" is defined as oral or intravenous drugs that are absorbed into the circulation;
• •Requirement of an indwelling catheter of any type; 28. Use of hypoxia-inducible factor (HIF) stabilizers or erythropoiesis-stimulating agents (ESA) within 6 weeks of randomization or during the treatment period;
• •General exclusions
• •Currently breastfeeding; or
• •Any condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would in the opinion of the Investigator increase the risk of participating in the study.