Pediatric Kidney Transplant Without Calcineurin Inhibitors
Summary
The purpose of this study is to see the effect of using drugs other than calcineurin inhibitors to improve the rate of kidney transplant failure. Kidney transplantation can help children with end-stage kidney disease. However, it has been difficult to find treatment for donor graft rejection that does not have a lot of side effects. Researchers hope to find treatments (immunosuppressants) with fewer side effects. One approach is to avoid using calcineurin inhibitors and to try a new drug known as sirolimus instead. Another is to use steroids less often. This study will test whether using sirolimus, fewer steroid treatments, MMF, and certain antibodies will improve long-term graft survival in children receiving kidney transplants from living donors.
Timeline
- Start
- 2001-02
- Primary completion
- 2004-08
- Completion
- 2006-08
Publications
- Results Harmon W, Meyers K, Ingelfinger J, McDonald R, McIntosh M, Ho M, Spaneas L, Palmer JA, Hawk M, Geehan C, Tinckam K, Hancock WW, Sayegh MH. Safety and efficacy of a calcineurin inhibitor avoidance regimen in pediatric renal transplantation. J Am Soc Nephrol. 2006 Jun;17(6):1735-45. doi: 10.1681/ASN.2006010049. Epub 2006 May 10.
- Results Iacomini J, Sayegh MH. Measuring T cell alloreactivity to predict kidney transplant outcomes: are we there yet? J Am Soc Nephrol. 2006 Feb;17(2):328-30. doi: 10.1681/ASN.2005121264. Epub 2005 Dec 28. No abstract available.
- Results Schachter AD, Meyers KE, Spaneas LD, Palmer JA, Salmanullah M, Baluarte J, Brayman KL, Harmon WE. Short sirolimus half-life in pediatric renal transplant recipients on a calcineurin inhibitor-free protocol. Pediatr Transplant. 2004 Apr;8(2):171-7. doi: 10.1046/j.1399-3046.2003.00148.x.
- Results Hoerning A, Koss K, Datta D, Boneschansker L, Jones CN, Wong IY, Irimia D, Calzadilla K, Benitez F, Hoyer PF, Harmon WE, Briscoe DM. Subsets of human CD4(+) regulatory T cells express the peripheral homing receptor CXCR3. Eur J Immunol. 2011 Aug;41(8):2291-302. doi: 10.1002/eji.201041095. Epub 2011 Jun 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daclizumab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Methylprednisolone | Other / unclassified | — | — |
| Subject | Mycophenolate Mofetil | Small molecule | 1200 mg/m2 | Oral |
| Subject | Prednisone | Other / unclassified | — | — |
| Subject | Sirolimus | Small molecule | — | Oral |
| Background | Atorvastatin | Small molecule | — | Oral |
| Background | Ganciclovir | Small molecule | — | Oral |
| Background | trimethoprim-sulfamethoxazole | Unknown | — | Oral |