Overview

Pediatric Kidney Transplant Without Calcineurin Inhibitors

Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to see the effect of using drugs other than calcineurin inhibitors to improve the rate of kidney transplant failure. Kidney transplantation can help children with end-stage kidney disease. However, it has been difficult to find treatment for donor graft rejection that does not have a lot of side effects. Researchers hope to find treatments (immunosuppressants) with fewer side effects. One approach is to avoid using calcineurin inhibitors and to try a new drug known as sirolimus instead. Another is to use steroids less often. This study will test whether using sirolimus, fewer steroid treatments, MMF, and certain antibodies will improve long-term graft survival in children receiving kidney transplants from living donors.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Atorvastatin
Atorvastatin Calcium
Calcineurin Inhibitors
Daclizumab
Everolimus
Ganciclovir
Ganciclovir triphosphate
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Mycophenolate mofetil
Mycophenolic Acid
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone
Sirolimus
Trimethoprim, Sulfamethoxazole Drug Combination
Criteria
Inclusion Criteria

Patients may be eligible for this study if they:

- Are 21 years of age and under.

- Are kidney recipients of living-donor grafts, except when living-donor grafts are
identically matched.

Exclusion Criteria

Patients will not be eligible for this study if they:

- Are recipients of identical (HLA matched) living-donor grafts.

- Are recipients of cadaver-donor grafts.

- Have certain abnormal kidney diseases that may return.

- Have failed 2 or more previous kidney transplants.

- Have fat abnormalities that are inherited or present at high levels.