A Study to Compare Treatment With Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant
Status:
Terminated
Trial end date:
2006-03-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare treatment with the new drug sirolimus (SRL) versus
the standard treatment with cyclosporine (CsA) or tacrolimus in children who have received
kidney transplants. SRL is a new medication that may prevent the body's immune system from
rejecting organ transplants.
After receiving a kidney transplant, the body recognizes the donated kidney as a foreign
invader and triggers the immune system to attack the kidney. This can lead to rejection of
the new kidney and a failed transplant. To help reduce the risk of kidney rejection,
transplant patients are given immunosuppressant drugs, which reduce the body's normal immune
response and allow the transplanted organ to function. CsA or tacrolimus are two drugs that
are often given to transplant patients. However, these are powerful drugs, and it can cause
serious side effects and put a patient at increased risk for infections. SRL is a new drug
that has been shown to reduce a transplant patient's chance of rejecting a new kidney,
without serious side effects. This study is necessary to test the safety and effectiveness of
SRL in children.
Phase:
Phase 3
Details
Lead Sponsor:
Boston Children's Hospital Boston Children’s Hospital