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 Doctors believe steroids might be safely withdrawn in patients that are receiving other maintenance therapies.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 This study evaluates whether steroid therapy can be withdrawn in a way that does not increase graft rejection.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