Lipid Management in Renal Transplant Recipients Using Evolocumab.

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Oct 28, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Evolocumab, which is designed to help lower cholesterol levels in people who have received a kidney transplant. Following a kidney transplant, many patients experience high cholesterol levels, which can increase the risk of heart disease—one of the leading causes of death in these individuals. The trial aims to evaluate how safe and effective Evolocumab is for kidney transplant recipients, particularly those who may not respond well to traditional cholesterol-lowering medications called statins, which can have side effects that are concerning for transplant patients.

To participate in the trial, you need to be an adult who has had a kidney transplant for at least a year and is between 18 and 85 years old. You should also have elevated cholesterol levels, specifically an LDL greater than 70 mg/dl, and may have other health issues like diabetes or a history of heart disease. The study will involve around 120 participants across three hospitals in Boston. If you join the trial, you can expect regular check-ups to monitor your health and how well the medication works for you. This research is important as it could lead to safer treatment options for managing cholesterol in kidney transplant patients.

Gender

ALL

Eligibility criteria

• 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.