drugset / Trial / NCT00141037
Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation
Phase 1/2
Completed
130 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Astellas Pharma Inc · collabHoffmann-La Roche · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2004-03
- Primary completion
- 2006-09
- Completion
- 2010-11
Publications
- Background Cole E, Landsberg D, Russell D, Zaltzman J, Kiberd B, Caravaggio C, Vasquez AR, Halloran P. A pilot study of steroid-free immunosuppression in the prevention of acute rejection in renal allograft recipients. Transplantation. 2001 Sep 15;72(5):845-50. doi: 10.1097/00007890-200109150-00018.
- Background Sarwal MM, Vidhun JR, Alexander SR, Satterwhite T, Millan M, Salvatierra O Jr. Continued superior outcomes with modification and lengthened follow-up of a steroid-avoidance pilot with extended daclizumab induction in pediatric renal transplantation. Transplantation. 2003 Nov 15;76(9):1331-9. doi: 10.1097/01.TP.0000092950.54184.67.
- Background Vidhun JR, Sarwal MM. Corticosteroid avoidance in pediatric renal transplantation. Pediatr Nephrol. 2005 Mar;20(3):418-26. doi: 10.1007/s00467-004-1786-4. Epub 2005 Feb 3.
- Background Vidhun JR, Sarwal MM. Corticosteroid avoidance in pediatric renal transplantation: can it be achieved? Paediatr Drugs. 2004;6(5):273-87. doi: 10.2165/00148581-200406050-00002.
- Results Sarwal MM, Ettenger RB, Dharnidharka V, Benfield M, Mathias R, Portale A, McDonald R, Harmon W, Kershaw D, Vehaskari VM, Kamil E, Baluarte HJ, Warady B, Tang L, Liu J, Li L, Naesens M, Sigdel T, Waskerwitz J, Salvatierra O. Complete steroid avoidance is effective and safe in children with renal transplants: a multicenter randomized trial with three-year follow-up. Am J Transplant. 2012 Oct;12(10):2719-29. doi: 10.1111/j.1600-6143.2012.04145.x. Epub 2012 Jun 13.
- Results Naesens M, Salvatierra O, Benfield M, Ettenger RB, Dharnidharka V, Harmon W, Mathias R, Sarwal MM; SNS01-NIH-CCTPT Multicenter Trial. Subclinical inflammation and chronic renal allograft injury in a randomized trial on steroid avoidance in pediatric kidney transplantation. Am J Transplant. 2012 Oct;12(10):2730-43. doi: 10.1111/j.1600-6143.2012.04144.x. Epub 2012 Jun 13.
- Results Li L, Khatri P, Sigdel TK, Tran T, Ying L, Vitalone MJ, Chen A, Hsieh S, Dai H, Zhang M, Naesens M, Zarkhin V, Sansanwal P, Chen R, Mindrinos M, Xiao W, Benfield M, Ettenger RB, Dharnidharka V, Mathias R, Portale A, McDonald R, Harmon W, Kershaw D, Vehaskari VM, Kamil E, Baluarte HJ, Warady B, Davis R, Butte AJ, Salvatierra O, Sarwal MM. A peripheral blood diagnostic test for acute rejection in renal transplantation. Am J Transplant. 2012 Oct;12(10):2710-8. doi: 10.1111/j.1600-6143.2012.04253.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daclizumab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Daclizumab | Monoclonal antibody | 2 mg/kg | — |
| Comparator | Prednisone | Other / unclassified | 0.1 mg/kg | — |
| Background | Ganciclovir | Small molecule | 5 mg/kg | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 600 mg/m2 | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 900 mg/m2 | Intravenous |
| Background | Sulfamethoxazole | Small molecule | 2 mg/kg | Oral |
| Background | Tacrolimus | Small molecule | 0.07 mg/kg | Oral |
| Background | Trimethoprim | Small molecule | 2 mg/kg | Oral |
| Background | Valganciclovir | Small molecule | — | Oral |