Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Over the last 40 years, corticosteroids (steroids) have been an important part of drug regimens used to prevent organ rejection and to maintain the immune health of individuals who have received organ transplants. Unfortunately, the negative physical effects of steroids can be severe, especially in children. The purpose of this study is to determine the safety and effectiveness of a steroid-free treatment regimen for children and adolescents who have received kidney (renal) transplants.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Astellas Pharma Inc; Hoffmann-La Roche
• Treatments: Daclizumab; Ganciclovir; Ganciclovir triphosphate; Immunoglobulin G; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Sulfamethoxazole; Tacrolimus; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Valganciclovir

Criteria

Inclusion Criteria:

• Primary recipient of a kidney transplant

• Meets site-specific transplant criteria

• Panel Reactive Antibody (PRA) of 20% or less

• Willing to use acceptable forms of contraception

• Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

• Previous treatment with steroids within 6 months prior to transplantation

• Received en-bloc kidney or other kidney that does not meet protocol-specified requirements

• Received an organ from an human leukocyte antigen (HLA) identical donor or a non-heart-beating donor

• Received a solid organ other than a kidney

• Received a bone marrow or hematopoietic stem cell transplant

• Received a repeat kidney transplant

• Currently receiving an investigational pharmacologic or biologic agent

• Human Immunodeficiency virus (HIV) infected or infected with another immunodeficiency virus

• Hypersensitivity to murine products or the study drugs or their formulations

• Inability to measure height accurately

• Pregnant or breastfeeding