A randomized double-blind, placebo controlled trial of steroid withdrawal after pediatric renal transplantation

American Journal of Transplantation

Volumn 10, Issue 1, 2010, Pages 81-88

  Benfield, M R ^a   Bartosh, S ^b   Ikle, D ^c   Warshaw, B ^d   Bridges, N ^e   Morrison, Y ^e   Harmon, W ^f  

^a University of Alabama at Birmingham   (United States)

^b UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^c Pharmaceutical Product Development   (United States)

^d EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e NATIONAL INSTITUTES OF HEALTH   (United States)

^f HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Growth after transplant; Kidney transplantation; Pediatric kidney transplant; Steroid withdrawal

Indexed keywords

BASILIXIMAB; COTRIMOXAZOLE; CYCLOSPORIN; METHYLPREDNISOLONE; PREDNISONE; RAPAMYCIN; TACROLIMUS;

ACUTE GRAFT REJECTION; ADOLESCENT; ADULT; ALLOGRAFT; ARTICLE; CANCER SURVIVAL; CHILD; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CUSHINGOID SYNDROME; DISEASE REGISTRY; DISEASE SURVEILLANCE; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; GRAFT FAILURE; GRAFT SURVIVAL; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; INCIDENCE; INFANT; INFORMED CONSENT; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; LYMPHOPROLIFERATIVE DISEASE; MAJOR CLINICAL STUDY; MALE; MORNING DOSAGE; OUTCOME ASSESSMENT; PATIENT INFORMATION; PATIENT SAFETY; PATIENT SELECTION; PEDIATRIC SURGERY; PNEUMOCYSTIS PNEUMONIA; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; RISK FACTOR; SCHOOL CHILD; STEROID THERAPY; SURVIVAL TIME; TREATMENT DURATION; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT;

ACUTE DISEASE; ADOLESCENT; ADRENAL CORTEX HORMONES; BODY HEIGHT; CHILD; CHILD, PRESCHOOL; DOUBLE-BLIND METHOD; FEMALE; GRAFT REJECTION; GRAFT SURVIVAL; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INFANT; KIDNEY TRANSPLANTATION; LYMPHOPROLIFERATIVE DISORDERS; MALE; RISK ASSESSMENT; TIME FACTORS; YOUNG ADULT;

EID: 72549098580     PISSN: 16006135     EISSN: 16006143     Source Type: Journal    
DOI: 10.1111/j.1600-6143.2009.02767.x     Document Type: Article

References (18)

1. Jabs K, Sullivan EK, Avner ED, Harmon WE. Alternate-day steroid dosing improves growth without adversely affecting graft survival or long-term graft function. A report of the North American Pediatric Renal Transplant Cooperative Study. Transplantation 1996 61 : 31 36.
2. Augustine JJ, Hricik DE. Steroid sparing in kidney transplantation: Changing paradigms, improving outcomes, and remaining questions. Clin J Am Soc Nephrol 2006 1 : 1080 1089.
3. Sinclair NR. The Canadian Multicentre Transplant Study Group. Low-dose steroid therapy in cyclosporine-treated renal transplant recipients with well-functioning grafts. CMAJ 1992 147 : 645 657.
4. Kasiske BL, Chakkera HA, Louis TA, Ma JZ. A meta-analysis of immunosuppression withdrawal trials in renal transplantation. J Am Soc Nephrol 2000 11 : 1910 1917.
5. Pascual J, Quereda C, Zamora J, Hernandez D. Steroid withdrawal in renal transplant patients on triple therapy with a calcineurin inhibitor and mycophenolate mofetil: A meta-analysis of randomized, controlled trials. Transplantation 2004 78 : 1548 1556.
6. McDonald RA, McDonald RA, Bartosh S, Ho PL, Harmon W. Incidence of PTLD in pediatric renal transplant recipients receiving basiliximab, calcineurin inhibitor, sirolimus and steroids. Am J Transplant 2008 8 : 984 989.
7. Benfield MR. Current status of kidney transplant: Update 2003. Pediatr Clin North Am 2003 50 : 1301 1334.
8. Pascual J, van Hooff JP, Salmela K, Lang P, Rigotti P, Budde K. Three-year observational follow-up of a multicenter, randomized trial on tacrolimus-based therapy with withdrawal of steroids or mycophenolate mofetil after renal transplant. Transplantation 2006 82 : 55 61.
9. Park JB, Kim SJ, Oh HY et al. Steroid withdrawal in living donor renal transplant recipients using tacrolimus and cyclosporine: A randomized prospective study. Transpl Int 2006 19 : 478 484.
10. Hasegawa A, Motoyama O, Shishido S et al. A prospective trial of steroid withdrawal after renal transplantation in children: Results obtained 1990 and 2002. Transplant Proc 2004 36 (2 Suppl 216S 219S.
11. Hamiwka LA, Burns A, Bell L. Prednisone withdrawal in pediatric kidney transplant recipients on tacrolimus-based immunosuppression: Four-year data. Pediatr Transplant 2006 10 : 337 344.
12. Hocker B, John U, Plank C et al. Successful withdrawal of steroids in pediatric renal transplant recipients receiving cyclosporine A and mycophenolate mofetil treatment: Results after four years. Transplantation 2004 78 : 228 234.
13. Ellis D, Shapiro R, Moritz M et al. Renal transplantation in children managed with lymphocyte depleting agents and low-dose maintenance tacrolimus monotherapy. Transplantation 2007 83 : 1563 1570.
14. Sarwal MM, Yorgin PD, Alexander S et al. Promising early outcomes with a novel, complete steroid avoidance immunosuppression protocol in pediatric renal transplantation. Transplantation 2001 72 : 13 21.
15. Pelletier RP, Akin B, Ferguson RM. Prospective, randomized trial of steroid withdrawal in kidney recipients treated with mycophenolate mofetil and cyclosporine. Clin Transplant 2006 20 : 10 18.
16. Laftavi MR, Stephan R, Stefanick B et al. Randomized prospective trial of early steroid withdrawal compared with low-dose steroids in renal transplant recipients using serial protocol biopsies to assess efficacy and safety. Surgery 2005 137 : 364 371.
17. Vanrenterghem Y, van Hooff JP, Squifflet JP et al. Minimization of immunosuppressive therapy after renal transplantation: Results of a randomized controlled trial. Am J Transplant 2005 5 : 87 95.
18. Opelz G, Dohler B, Laux G. Long-term prospective study of steroid withdrawal in kidney and heart transplant recipients. Am J Transplant 2005 5 (4 Pt 1 720 728.