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

Condition	Intervention
Kidney Diseases Kidney Transplantation	Drug: Daclizumab  Drug: Mycophenolate mofetil  Drug: Prednisone  Drug: Tacrolimus

Further Study Details: 

Primary Outcomes: Efficacy, as measured by the difference in the change of standardized height at 1 year; safety, as measured by the rate at 12 months of biopsy-proven acute rejection
Expected Total Enrollment:  130

Corticosteroids have been a cornerstone of immunosuppressive therapy for kidney transplantation for over 40 years. However, poor growth and bone loss caused by the use of corticosteroids are devastating to pediatric kidney recipients. The negative physical implications of corticosteroid use also greatly impacts patients'''' compliance to their prescribed corticosteroid-containing regimens. The development of a corticosteroid-free regimen for post-transplant pediatric patients is sorely needed. This study will evaluate the safety and efficacy of a corticosteroid-free treatment regimen in children and adolescents who have received kidney transplants, compared to a standard of care regimen including corticosteroids. Participants in this study will be pediatric patients with end-stage kidney disease who will undergo kidney transplantation at the start of the study.

Patients will participate in this study for 3 years. Participants will be randomly assigned to one of two groups. Group 1 patients will receive daclizumab, tacrolimus, mycophenolate mofetil (MMF), and prednisone. Group 1 patients will receive daclizumab prior to transplantation and at Weeks 2, 4, 6, and 8 after transplantation. Group 1 patients will receive prednisone at the time of transplantation and will undergo gradual prednisone tapering post-transplant. Group 2 patients will receive daclizumab, tacrolimus, MMF, but no prednisone. Group 2 patients will receive daclizumab prior to transplantation, at Weeks 2, 4, 6, 8, and 11, and at Months 4, 5 and 6 after transplantation. To prevent opportunistic infections, all patients will receive prophylactic medications beginning after transplantation.

There will be 23 study visits during the 3-year study. A physical exam, medication history, adverse events reporting, blood pressure readings, growth assessment, and blood collection will occur at most visits. At the time of transplantation, patients will have a kidney biopsy. Patients will also undergo cataract screening within 4 months of transplantation.

Ages Eligible for Study:  up to  21 Years,  Genders Eligible for Study:  Both

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 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
• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00141037

Study chairs or principal investigators

Minnie Sarwal, MD, PhD,  Study Chair,  Stanford University   
Oscar Salvatierra, MD,  Principal Investigator,  Pediatric Kidney Transplant Program, Stanford University Medical Center, Stanford Hospital and Clinics   

Study ID Numbers:  DAIT SNS01
Last Updated:  August 31, 2005
Record first received:  August 1, 2005
ClinicalTrials.gov Identifier:  NCT00141037
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-06