Lipid Management in Renal Transplant Recipients: A Pilot Study Evaluating the Use of PCSK-9 Inhibitor, Evolocumab.

Description

Cardiovascular disease is the leading cause of mortality after renal transplantation, accounting for more than 30% of deaths. Elevated lipid levels (hyperlipidemia) are a frequent finding following transplantation and the immunosuppressive medications play a central role in the development or worsening of hyperlipidemia. In the general population, the correlation between elevated serum cholesterol and increased risk of cardiovascular disease is well established and the reduction in serum LDL cholesterol has proved to significantly reduce both morbidity and mortality. Statin based drugs are the standard of care in the management of hyperlipidemia. Commonly used statin-based drugs include atorvastatin (Lipitor), fluvastatin (Lescol, Lescol XL), lovastatin (Mevacor, Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), simvastatin (Zocor), and pitavastatin (Livalo). These drugs have been proven to lower lipid levels as well as cardiovascular risk. However, statin-based drugs also c

Trial Eligibility

Inclusion Criteria: * Adult renal transplant recipients greater than 1-year post-transplantation, men and women between 18 and 85 years of age, inclusive. * Any patient with documented ASCVD or diabetes and 1 or more risk factors for ASCVD, including, but not limited to obesity, inactive lifestyle, hypertension, smoking, and family history. and an LDL \>70 mg/dl (Highest-Risk Patients) * Any patient not classified as one of our highest-risk patients, that has an LDL \>100 mg/dl Exclusion Criteria: * Patients currently enrolled in another interventional clinical trial. * Patients being actively treated for cellular or antibody-mediated rejection. * Serious hypersensitivity to Evolocumab or any component of the formulation. * Patients who are pregnant or planning a pregnancy in the next one year.

Study Info

Interventions

Locations Recruiting

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