Lipid Management in Renal Transplant Recipients Using Evolocumab.
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
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 cause a variety of side
effects. While the most commonly encountered side effects are toxicity to the liver and
muscles, a few others have also been known to cause increased excretion of protein in the
urine and kidney failure. These side effects are also more common in a renal transplant
recipient due to the simultaneous administration of drugs that prevent rejection. Therefore,
there is an emergent need for newer drugs which are both efficient and safe especially in
this population PCSK-9 inhibitors (Proprotein Convertase Subtilisin Kinase-9 inhibitors) are
a new class of drugs that are highly efficient in lowering lipid levels in the general
population. However, an exclusive trial involving kidney transplant recipients is yet to be
done. Through this study, we would like to evaluate the safety and tolerability of Evolocumab
(trade name: Repatha) which is a PCSK-9 inhibitor developed by Amgen, Inc in renal transplant
recipients. The study would involve a total of 120 patients across 3 different hospitals in
Boston, Massachusetts.