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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Treatments: Cyclosporine; Cyclosporins; Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria

Your child may be eligible for this study if he/she:

• Has received a kidney transplant.

• Has experienced 1 or more episodes of acute rejection or chronic rejection; a rejection episode must have responded to treatment and have occurred at least 30 days before study enrollment.

• Has stable kidney function at the time of study enrollment.

• Is 20 years of age or younger.

• Has written informed consent of parent or guardian if under the age of 18.

• Agrees to use birth control during the study and for 3 months following treatment.

Exclusion Criteria

Your child will not be eligible for this study if he/she:

• Has a history of cancer.

• Has received a multi-organ transplant (more than a kidney).

• Has an active infection.

• Has an abnormal chest X-ray.

• Cannot provide a kidney biopsy at time of study entry.

• Is allergic to sirolimus.

• Has received experimental drugs within 4 weeks of study entry.

• Is pregnant.