Safety and efficacy of a calcineurin inhibitor avoidance regimen in pediatric renal transplantation

Journal of the American Society of Nephrology

Volumn 17, Issue 6, 2006, Pages 1735-1745

  Harmon, William ^a,f   Meyers, Kevin ^b   Ingelfinger, Julie ^c   McDonald, Ruth ^d   McIntosh, Matthew ^e   Ho, Martin ^e   Spaneas, Leslie ^a   Palmer, Jo Ann ^b   Hawk, Marena ^d   Geehan, Chris ^a   Tinckam, Kathryn ^a   Hancock, Wayne W ^b   Sayegh, Mohamed H ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^c MASSACHUSETTS GENERAL HOSPITAL   (United States)

^d SEATTLE CHILDREN S RESEARCH INSTITUTE   (United States)

^e EMMES CORPORATION   (United States)

^f BOSTON CHILDREN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BASILIXIMAB; CALCINEURIN INHIBITOR; HLA ANTIBODY; HLA CLASS 1 ANTIBODY; HLA CLASS 2 ANTIBODY; METHYLPREDNISOLONE SODIUM SUCCINATE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PREDNISONE; RAPAMYCIN; RITUXIMAB; THYMOCYTE ANTIBODY; UNCLASSIFIED DRUG;

ADOLESCENT; ANEMIA; ANTIBODY DETECTION; ANTIBODY PRODUCTION; ARTICLE; CELL INFILTRATION; CLINICAL ARTICLE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; EPSTEIN BARR VIRUS; ESOPHAGUS CANDIDIASIS; GRAFT REJECTION; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY TRANSPLANTATION; LIVING DONOR; LOW DRUG DOSE; LUNG ASPERGILLOSIS; LYMPHOPROLIFERATIVE DISEASE; MOUTH ULCER; NEUTROPENIA; PAPILLEDEMA; PEDIATRIC SURGERY; PILOT STUDY; PNEUMOCYSTIS PNEUMONIA; PRESCHOOL CHILD; PRIORITY JOURNAL; PROTEINURIA; SCHOOL CHILD; URINARY TRACT INFECTION; URINOMA; VASCULITIS; VIRUS INFECTION; WOUND HEALING IMPAIRMENT;

EID: 33646915970     PISSN: 10466673     EISSN: None     Source Type: Journal    
DOI: 10.1681/ASN.2006010049     Document Type: Article

References (64)

1. Fine RN: Renal transplantation for children: The only realistic choice. Kidney Int Suppl 17: S15-S17, 1985
2. Bartosh SM, Leverson G, Robillard D, Sollinger HW: Long-term outcomes in pediatric renal transplant recipients who survive into adulthood. Transplantation 76:1195-1200, 2003
3. Broyer M, Le Bihan C, Charbit M, Guest G, Tete MJ, Gagnadoux MF, Niaudet P: Long-term social outcome of children after kidney transplantation. Transplantation 77: 1033-1037, 2004
4. Ettenger RB, Blifeld C, Prince H, Gradus DB, Cho S, Sekiya N, Salusky IB, Fine RN: The pediatric nephrologist's dilemma: Growth after renal transplantation and its interaction with age as a possible immunologic variable. J Pediatr 111: 1022-1025, 1987
5. Benfield MR, McDonald RA, Bartosh S, Ho PL, Harmon W: Changing trends in pediatric transplantation: 2001 Annual Report of the North American Pediatric Renal Transplant Cooperative Study. Pediatr Transplant 7: 321-335, 2003
6. Harmon WE, McDonald RA, Reyes JD, Bridges ND, Sweet SC, Sommers CM, Guidinger MK: Pediatric transplantation, 1994-2003. Am J Transplant 5: 887-903, 2005
7. Tejani A, Ho PL, Emmett L, Stablein DM, North American Pediatric Renal Transplant Cooperative S: Reduction in acute rejections decreases chronic rejection graft failure in children: A report of the North American Pediatric Renal Transplant Cooperative Study (NAPRTCS). Am J Transplant 2: 142-147, 2002
8. Tejani A, Stablein DM, Donaldson L, Harmon WE, Alexander SR, Kohaut E, Emmett L, Fine RN: Steady improvement in short-term graft survival of pediatric renal transplants: The NAPRTCS experience. Clin Transpl 95-110, 1999
9. Tejani A, Sullivan EK: The impact of acute rejection on chronic rejection: A report of the North American Pediatric Renal Transplant Cooperative Study. Pediatric Transplantation 4: 107-111, 2000
10. Duzova A, Buyan N, Bakkaloglu M, Dalgic A, Soylemezoglu O, Besbas N, Bakkaloglu A: Triple immunosuppression with or without basiliximab in pediatric renal transplantation: Acute rejection rates at one year. Transplant Proc 35: 2878-2880, 2003
11. Montini G, Murer L, Ghio L, Pietrobon B, Ginevri F, Ferraresso M, Cardillo M, Scalamogna M, Perfumo F, Edefonti A, Zanon GF, Zacchello G: One-year results of basiliximab induction and tacrolimus associated with sequential steroid and MMF treatment in pediatric kidney transplant recipient. Transpl Int 18: 36-42, 2005
12. Swiatecka-Urban A, Garcia C, Feuerstein D, Suzuki S, Devarajan P, Schechner R, Greenstein S, Tellis V, Kaskel F: Basiliximab induction improves the outcome of renal transplants in children and adolescents. Pediatr Nephrol 16: 693-696, 2001
13. Vester U, Kranz B, Testa G, Malago M, Beelen D, Broelsch CE, Hoyer PF: Efficacy and tolerability of interleukin-2 receptor blockade with basiliximab in pediatric renal transplant recipients. Pediatr Transplant 5: 297-301, 2001
14. Cransberg K, Marlies Cornelissen EA, Davin JC, Van Hoeck KJ, Lilien MR, Stijnen T, Nauta J: Improved outcome of pediatric kidney transplantations in the Netherlands: Effect of the introduction of mycophenolate mofetil? Pediatr Transplant 9: 104-111, 2005
15. Jungraithmayr T, Staskewitz A, Kirste G, Boswald M, Bulla M, Burghard R, Dippell J, Greiner C, Helmchen U, Klare B, Klaus G, Leichter HE, Mihatsch MJ, Michalk DV, Misselwitz J, Plank C, Querfeld U, Weber LT, Wiesel M, Tonshoff B, Zimmerhackl LB; for the German Pediatric Renal Transplantation Study G: Pediatric renal transplantation with mycophenolate mofetil-based immunosuppression without induction: Results after three years. Transplantation 75: 454-461, 2003
16. Khositseth S, Matas A, Cook ME, Gillingham KJ, Chavers BM: Thymoglobulin versus ATGAM induction therapy in pediatric kidney transplant recipients: A single-center report. Transplantation 79: 958-963, 2005
17. Lufft V, Tusch G, Offner G, Brunkhorst R: Kidney transplantation in children: Impact of young recipient age on graft survival. Nephrol Dial Transplant 18: 2141-2146, 2003
18. Neu AM, Ho PL, Fine RN, Furth SL, Fivush BA: Tacrolimus vs. cyclosporine A as primary immunosuppression in pediatric renal transplantation: A NAPRTCS study. Pediatr Transplant 7: 217-222, 2003
19. Trompeter R, Filler G, Webb NJ, Watson AR, Milford DV, Tyden G, Grenda R, Janda J, Hughes D, Ehrich JH, Klare B, Zacchello G, Bjorn Brekke I, McGraw M, Perner F, Ghio L, Balzar E, Friman S, Gusmano R, Stolpe J: Randomized trial of tacrolimus versus cyclosporin microemulsion in renal transplantation. Pediatr Nephrol 17: 141-149, 2002
20. Cecka JM: The OPTN/UNOS Renal Transplant Registry. In: Clinical Transplants 2004, edited by Cecka JM, Terasaki PI, Los Angeles, UCLA Immunogenetics Center, 2004, pp 1-17
21. Elshihabi I, Chavers B, Donaldson L, Emmett L, Tejani A: Continuing improvement in cadaver donor graft survival in North American children: The 1998 annual report of the North American Pediatric Renal Transplant Cooperative Study (NAPRTCS). Pediatr Transplant 4: 235-246, 2000
22. McDonald R, Donaldson L, Emmett L, Tejani A: A decade of living donor transplantation in North American children: The 1998 annual report of the North American Pediatric Renal Transplant Cooperative Study (NAPRTCS). Pediatr Transplant 4: 221-234, 2000
23. Kari JA, Trompeter RS: What is the calcineurin inhibitor of choice for pediatric renal transplantation? Pediatr Transplant 8: 437-444, 2004
24. Kahan BD: Cyclosporine. N Engl J Med 321:1725-1738, 1989
25. Jankauskiene A, Druskis V, Laurinavicius A: Cyclosporine nephrotoxicity: Associated allograft dysfunction at low trough concentration. Clin Nephrol 56: S27-S29, 2001
26. Li M, Nicholls KM, Becker GJ: Risk factors for late renal allograft dysfunction: Effects of baseline glomerular size. J Nephrol 15: 620-625, 2002
27. Pape L, Ehrich JH, Offner G: Cyclosporine in pediatric kidney transplantation. Transplant Proc 36[Suppl]: 203S-207S, 2004
28. Sarwal MM, Yorgin PD, Alexander S, Millan MT, Belson A, Belanger N, Granucci L, Major C, Costaglio C, Sanchez J, Orlandi P, Salvatierra O Jr: Promising early outcomes with a novel, complete steroid avoidance immunosuppression protocol in pediatric renal transplantation. Transplantation 72: 13-21, 2001
29. 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 76: 1331-1339, 2003
30. Keogh A: Calcineurin inhibitors in heart transplantation. J Heart Lung Transplant 23[Suppl]: S202-S206, 2004
31. Wong W, Venetz J-P, Tolkoff-Rubin N, Pascual M: 2005 immunosuppressive strategies in kidney transplantation: Which role for the calcineurin inhibitors? Transplantation 80: 289-296, 2005
32. Smith JM, Nemeth TL, McDonald RA: Current immunosuppressive agents in pediatric renal transplantation: Efficacy, side-effects and utilization. Pediatr Transplant 8: 445-453, 2004
33. Vester U, Kranz B, Nadalin S, Paul A, Becker J, Hoyer PF: Sirolimus rescue of renal failure in children after combined liver-kidney transplantation. Pediatr Nephrol 20: 686-689, 2005
34. Butani L: Investigation of pediatric renal transplant recipients with heavy proteinuria after sirolimus rescue. Transplantation 78: 1362-1366, 2004
35. 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 8: 171-177, 2004
36. Ettenger RB, Grimm EM: Safety and efficacy of TOR inhibitors in pediatric renal transplant recipients. Am J Kidney Dis 38[Suppl 2]: S22-S28, 2001
37. Kahan BD, Podbielski J, Napoli KL, Katz SM, Meier-Kriesche HU, Van Buren CT: Immunosuppressive effects and safety of a sirolimus/cyclosporine combination regimen for renal transplantation. Transplantation 66: 1040-1046, 1998
38. MacDonald A, Scarola J, Burke JT, Zimmerman JJ: Clinical pharmacokinetics and therapeutic drug monitoring of sirolimus. Clin Ther 22[Suppl B]: B101-B121, 2000
39. Mulay AV, Hussain N, Fergusson D, Knoll GA: Calcineurin inhibitor withdrawal from sirolimus-based therapy in kidney transplantation: A systematic review of randomized trials. Am J Transplant 5: 1748-1756, 2005
40. Racusen LC, Solez K, Colvin RB, Bonsib SM, Castro MC, Cavallo T, Croker BP, Demetris AJ, Drachenberg CB, Fogo AB, Furness P, Gaber LW, Gibson IW, Glotz D, Goldberg JC, Grande J, Halloran PF, Hansen HE, Hartley B, Hayry PJ, Hill CM, Hoffman EO, Hunsicker LG, Lindblad AS, Yamaguchi Y: The Banff 97 working classification of renal allograft pathology. Kidney Int 55: 713-723, 1999
41. Nankivell BJ, Borrows RJ, Fung CLS, O'Connell PJ, Allen RDM, Chapman JR: The natural history of chronic allograft nephropathy. N Engl J Med 349: 2326-2333, 2003
42. Chapman JR, O'Connell PJ, Nankivell BJ: Chronic renal allograft dysfunction. J Am Soc Nephrol 16: 3015-3026, 2005
43. Nankivell BJ, Borrows RJ, Fung CLS, O'Connell PJ, Chapman JR, Allen RDM: Calcineurin inhibitor nephrotoxicity: Longitudinal assessment by protocol histology. Transplantation 78: 557, 2004
44. Morales JM, Wramner L, Kreis H, Durand D, Campistol JM, Andres A, Arenas J, Negre E, Burke JT, Groth CG: Sirolimus does not exhibit nephrotoxicity compared to cyclosporine in renal transplant recipients. Am J Transplant 2: 436-442, 2002
45. Flechner SM, Goldfarb D, Modlin C, Feng J, Krishnamurthi V, Mastroianni B, Savas K, Cook DJ, Novick AC: Kidney transplantation without calcineurin inhibitor drugs: A prospective, randomized trial of sirolimus versus cyclosporine. Transplantation 74: 1070-1076, 2002
46. Flechner SM, Kurian SM, Solez K, Cook DJ, Burke JT, Rollin H, Hammond JA, Whisenant T, Lanigan CM, Head SR, Salomon DR: De novo kidney transplantation without use of calcineurin inhibitors preserves renal structure and function at two years. Am J Transplant 4: 1776-1785, 2004
47. Bates WD, Davies DR, Welsh K, Gray DW, Fuggle SV, Morris PJ: An evaluation of the Banff classification of early renal allograft biopsies and correlation with outcome. Nephrol Dial Transplant 14: 2364-2369, 1999
48. Dean DE, Kamath S, Peddi VR, Schroeder TJ, First MR, Cavallo T: A blinded retrospective analysis of renal allograft pathology using the Banff schema: Implications for clinical management. Transplantation 68: 642-645, 1999
49. Masin-Spasovska J, Spasovski G, Dzikova S, Petrusevska G, Dimova B, Lekovski L, Popov Z, Ivanovski N, Polenakovic M: The evolution of untreated borderline and subclinical rejections at first month kidney allograft biopsy in comparison with histological changes at 6 months protocol biopsies. Prilozi 26: 25-33, 2005
50. Roberts IS, Reddy S, Russell C, Davies DR, Friend PJ, Handa AI, Morris PJ: Subclinical rejection and borderline changes in early protocol biopsy specimens after renal transplantation. Transplantation 77: 1194-1198, 2004
51. Saad R, Gritsch HA, Shapiro R, Jordan M, Vivas C, Scantlebury V, Demetris AJ, Randhawa PS: Clinical significance of renal allograft biopsies with "borderline changes," as defined in the Banff schema. Transplantation 64: 992-995, 1997
52. Birk PE, Stannard KM, Konrad HB, Blydt-Hansen TD, Ogborn MR, Cheang MS, Gartner JG, Gibson IW: Surveillance biopsies are superior to functional studies for the diagnosis of acute and chronic renal allograft pathology in children. Pediatr Transplant 8: 29-38, 2004
53. Schwarz A, Gwinner W, Hiss M, Radermacher J, Mengel M, Haller H: Safety and adequacy of renal transplant protocol biopsies. Am J Transplant 5: 1992-1996, 2005
54. Shimizu A, Yamada K, Meehan SM, Sachs DH, Colvin RB: Acceptance reaction: Intragraft events associated with tolerance to renal allografts in miniature swine. J Am Soc Nephrol 11: 2371-2380, 2000
55. Christiaans MH, Overhof-de Roos R, Nieman F, van Hooff JP, van den Berg-Loonen EM: Donor-specific antibodies after transplantation by flow cytometry: Relative change in fluorescence ratio most sensitive risk factor for graft survival. Transplantation 65: 427-433, 1998
56. Lee P-C, Terasaki PI, Takemoto SK, Lee P-H, Hung C-J, Chen Y-L, Tsai A, Lei H-Y: All chronic rejection failures of kidney transplants were preceded by the development of HLA antibodies. Transplantation 74: 1192-1194, 2002
57. McKenna RM, Takemoto SK, Terasaki PI: Anti-HLA antibodies after solid organ transplantation. Transplantation 69: 319-326, 2000
58. Pelletier RP, Hennessy PK, Adams PW, VanBuskirk AM, Ferguson RM, Orosz CG: Clinical significance of MHC-reactive alloantibodies that develop after kidney or kidney-pancreas transplantation. Am J Transplant 2: 134-141, 2002
59. Terasaki PI, Ozawa M: Predicting kidney graft failure by HLA antibodies: A prospective trial. Am J Transplant 4: 438-443, 2004
60. Worthington JE, Martin S, Al-Husseini DM, Dyer PA, Johnson RWG: Posttransplantation production of donor HLA-specific antibodies as a predictor of renal transplant outcome. Transplantation 75: 1034-1040, 2003
61. Flechner SM, Feng J, Mastroianni B, Savas K, Arnovitz J, Moneim H, Modlin CS, Goldfarb D, Cook DJ, Novick AC: The effect of 2-gram versus 1-gram concentration controlled mycophenolate mofetil on renal transplant outcomes using sirolimus-based calcineurin inhibitor drug-free immunosuppression. Transplantation 79: 926-934, 2005
62. Fritsche L, Budde K, Dragun D, Einecke G, Diekmann F, Neumayer H-H: Testosterone concentrations and sirolimus in male renal transplant patients. Am J Transplant 4: 130-131, 2004
63. Kaczmarek I, Groetzner J, Adamidis I, Landwehr P, Mueller M, Vogeser M, Gerstorfer M, Uberfuhr P, Meiser B, Reichart B: Sirolimus impairs gonadal function in heart transplant recipients. Am J Transplant 4: 1084-1088, 2004
64. Lee S, Coco M, Greenstein SM, Schechner RS, Tellis VA, Glicklich DG: The effect of sirolimus on sex hormone levels of male renal transplant recipients. Clin Transplant 19:162-167, 2005