Kidney Transplantation Clinical Trial
Official title:
Randomized, Multi-Center Comparative Trial of Tacrolimus w/Steroids and Standard Daclizumab Induction vs a Novel Steroid-Free Tacrolimus Based Immunosuppression Protocol w/ Extended Daclizumab Induction in Pediatric Renal Transplantation
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.
Corticosteroids (steroids) have been a cornerstone of immunosuppressive therapy for kidney
(renal) transplantation for over 40 years. However, poor growth and bone loss caused by the
use of steroids are devastating to pediatric kidney recipients. The negative physical
implications of steroid use also greatly impacts patients' compliance to their prescribed
steroid-containing regimens.
The development of a steroid-free regimen for post-transplant pediatric patients is sorely
needed. This study will evaluate the safety and efficacy of a steroid-free based treatment
regimen in children and adolescents who have received kidney transplants, compared to a
standard of care steroid-based regimen. 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 randomized (1:1)
to one of two groups. The study includes 23 study visits over 3 years. 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, participants
will have a kidney biopsy. Participants will also undergo cataract screening within 4 months
of transplantation.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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