Overview

Steroid Withdrawal in Pediatric Kidney Transplant Recipients

Status:
Terminated
Trial end date:
2005-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to examine the effects of withdrawing steroids on graft rejection and kidney functions in kidney transplant recipients between the ages of 0 and 20 years (prior to their 21st birthday). Graft survival has improved in recent years in children with kidney transplants. One bad side effect of steroid maintenance therapy has been growth retardation. Doctors believe steroids might be safely withdrawn in patients that are receiving other maintenance therapies. If steroids are removed, children might catch up in their growth and also might have fewer side effects of other kinds. This study evaluates whether steroid therapy can be withdrawn in a way that does not increase graft rejection.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Cooperative Clinical Trials in Pediatric Transplantation
Treatments:
Basiliximab
Cyclosporine
Cyclosporins
Everolimus
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone
Sirolimus
Sulfamethoxazole
Tacrolimus
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
Criteria
Inclusion Criteria:

Patients may be eligible for this study if they:

- Are between the ages of 0 and 20 years (prior to their 21st birthday)

- Are receiving their first living related (e.g.,kidney from a relative or unrelated
donor) or cadaver donor transplant

- Are willing to practice an acceptable method of birth control during the study, if
women able to have children

Exclusion Criteria:

Patients will not be eligible for this study if they:

- Have received multiple organs

- Have received 2 or more transplants

- Have an active infection (including tuberculosis), or cancer

- Have used an experimental agent within 4 weeks of transplantation