Alirocumab in Patients on a Stable Dialysis Regimen (NCT03480568)

Usually NOT eligible if any of the following apply:

• Exclusion Criteria:
• LDL-cholesterol level of \< 70 mg/dL.
• Any contraindication to subcutaneous injections.
• Patients on statin and/or ezetimibe therapy will have their cholesterol-lowering therapy continued as is without change during the time of the study.
• History of any allergy or intolerance to the study drug or drugs of the same class.
• A history of MI, PCI, CABG surgery, TIA, CVA, or PAD events within 3 months of enrollment.
• History of malignant cancer within the past 3 years, excepting basal cell skin cancer or cervical cancer in situ.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of the drug and for 2 weeks after the last injection of the drug. Highly effective methods of contraception include:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
• Male sterilization (at least 6 months prior to enrollment). For female patients in the study, the vasectomized male partner should be the sole partner for that patient.
• Use of oral (estrogen and/or progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception.