Evolocumab In Advanced Chronic Kidney Disease Trial

Exclusion Criteria

• •Age \>80 years
• •Expected survival \< 1 year
• •Transplant expected within \< 1 year
• •Active liver disease (history of cirrhosis, ALT or AST \> 2x ULN)
• •CPK \> 5x ULN at screening
• •Malignancy within 5 years except for non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma
• •Subject has received drugs that are strong inhibitors of cytochrome P-450 3A4 within 1 month prior to randomization or is likely to require such treatment during the study period
• •Currently enrolled in another interventional study
• •Female subject who has not used at least (1) effective method of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment and for an additional 15 weeks after the end of treatment, unless the subject is sterilized or postmenopausal.
• •* Effective measures of birth control include surgical sterilization, barrier methods, hormonal contraceptives and intrauterine devices.
• •Pregnant or breast-feeding subjects
• •Known sensitivity or intolerance to study medications
• •The following additional criteria will be utilized to exclude individuals from participating in the PET substudy:
• •Severe asthma or obstructive lung disease defined by
• •* Hospitalization for asthma or obstructive lung disease within 8 weeks
• •* Use of oral steroids for lung disease within 8 weeks
• •* Chronic oxygen therapy
• •* Use of rescue inhalers ≥three times weekly in the previous 4 weeks
• •History of seizures
• •Second or third-degree AV block, unless a functioning pacemaker is present
• •Sinus node dysfunction unless a functioning pacemaker is present