Pediatric renal transplantation with mycophenolate mofetil-based immunosuppression without induction: results after three years1,2

Jungraithmayr, Therese; Staskewitz, Astrid; Kirste, Günter; Böswald, M.; Bulla, M; Burghard, R.; Dippell, J; Greiner, C; Helmchen, Udo; Klare, B; Klaus, Günter; Leichter, Heinz E.; Mihatsch, Michael J.; Michalk, Dietrich; Misselwitz, Joachim; Plank, Christian; Querfeld, Uwe; Weber, Lutz T.; Wiesel, M.; Tönshoff, Burkhard; Zimmerhackl, Lothar Bernd

doi:10.1097/01.tp.0000045748.95874.64

Cited by 64 publications

(49 citation statements)

References 28 publications

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“…In children, the peak concentration of MPA occurs at approximately 2.5 h after the administration of EC-MPS [15] compared to 1-2 h with MMF [16], which is consistent with findings in adult recipients [10]. In patients receiving cyclosporine (CsA), a single-dose pharmacokinetic study of EC-MPS in children aged [5][6][7][8][9][10][11][12][13][14][15][16] years has demonstrated that 450 mg/m 2 of EC-MPS provides similar MPA exposure (area under the curve, AUC) to 600 mg/m 2 MMF [15,16]. There are no data available, however, on the long-term pharmacokinetics of EC-MPS in children.…”

Section: Introductionsupporting

confidence: 70%

“…In pediatric renal transplantation, a multicenter trial has demonstrated that drug therapy with the mycophenolate mofetil (MMF) formulation of MPA significantly reduces acute rejection and graft loss relative to that in historical controls receiving azathioprine [4]. While randomized trials in the pediatric population are lacking, other prospective [5,6] and retrospective [7][8][9] studies in children have consistently shown that MMF therapy is effective in preventing acute rejection and associated with good graft survival rates and an acceptable safety profile.…”

Section: Introductionmentioning

confidence: 96%

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Enteric-coated mycophenolate sodium in de novo pediatric renal transplant patients

et al. 2009

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Data on the use of enteric-coated mycophenolic acid (EC-MPS) in pediatric transplantation cases are scarce. We undertook a 12-month, multicenter, open-label pilot study in which 16 de novo renal transplant patients aged 5-16 years received EC-MPS with cyclosporine A microemulsion (CsA-ME), steroids, and anti-interleukin-2 receptor antibody induction. The mean dose of EC-MPS was 916 +/- 93 mg/m(2) per day during weeks 1-2, 810 +/- 193 mg/m(2) per day during months 3-6, and 827 +/- 153 mg/m(2) per day during months 6-12. The mean CsA C(2) level exceeded target range up to month 6 post-transplant. Efficacy failure (biopsy-proven acute rejection, graft loss, death or loss to follow-up) occurred in two patients: one patient with primary non-function underwent nephrectomy, and one patient experienced biopsy-proven acute rejection (Grade 1B, day 344) following EC-MPS dose reduction. There were no deaths. Creatinine clearance (Schwartz) was 103 +/- 30 mL/min per 1.73 m(2) at month 6 and 100 +/- 16 mL/min per 1.73 m(2) at month 12. The majority of adverse events were mild or moderate (101/126, 80.2%). In this pilot study, EC-MPS 450 mg/m(2) administered twice daily with CsA, steroids, and interleukin-2 antibody induction resulted in a low rate of rejection with good renal function in a pediatric population. However, a larger, controlled trial is required to confirm these results.

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Section: Introductionsupporting

confidence: 70%

Section: Introductionmentioning

confidence: 96%

Enteric-coated mycophenolate sodium in de novo pediatric renal transplant patients

et al. 2009

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“…This popularity of mycophenolate reflects its proven efficacy in reducing risk for acute renal rejection and its safety and tolerability profile. The incidence of acute rejection is markedly lower, ranging from 15 to 35%, in patients who received MMF compared with those who received either azathioprine or no antimetabolite in combination with a CNI and corticosteroids (85)(86)(87)(88)(89). MMF has also been found to improve 5-year outcome in pediatric renal transplant recipients and prolong half-life of the graft (90).…”

Section: Pediatric Transplantationmentioning

confidence: 94%

Consensus Report on Therapeutic Drug Monitoring of Mycophenolic Acid in Solid Organ Transplantation

Kuypers¹,

Meur²,

Cantarovich³

et al. 2010

Clinical Journal of the American Society of Nephrology

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285

252

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“…In this respect, we [22,23] and other researchers [24,25] have shown that Tac-and MMF-based immunosuppression is related to better allograft function and protection against allograft deterioration than CsA or azathioprine immunosuppressive regimens. Therefore, the better renal function observed in both our MP-VLD and MP-LSW groups (both on Tac and MMF) at month 16 was an expected finding.…”

Section: Discussionmentioning

confidence: 99%

A study on strategies for improving growth and body composition after renal transplantation

Ferraris

Pasqualini²,

Alonso³

et al. 2010

Pediatr Nephrol

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Allograft function and metabolic effects of four treatment regimens, namely, methylprednisone (MP) standard dose (MP-STD), deflazacort (DFZ), MP-late steroid withdrawal (MP-LSW), and MP-very low dose (MP-VLD), were evaluated in prepubertal patients. MP was decreased by month 4 post-transplantation to 0.2 mg/kg/day in MP-STD and DFZ patients and to <0.1 mg/kg/day in MP-LSW and MP-VLD patients. Starting in month 16 post-transplant, MP was switched to DFZ in the DFZ group and totally withdrawn in the MP-LSW group. Creatinine clearance diminished in the MP-STD and MP-LSW groups from 77 +/- 6 to 63 +/- 6 ml/min/1.73 m(2)and from 103 +/- 5 to 78 +/- 3 ml/min/1.73 m(2), respectively (p < 0.01 and p < 0.001, respectively). Height increased >0.5 SDS only in the MP-LSW and MP-VLD groups. The body mass index and fat body mass for height-age increased only in the MP-STD patients (p < 0.05 and p < 0.01, respectively). Fat body mass decreased in the DFZ group (p < 0.05), total cholesterol and LDL-cholesterol increased in the MP-STD group, while LDL-cholesterol and total cholesterol/HDL-cholesterol ratio decreased in the DFZ group (p < 0.01). Lumbar spine bone mineral density (BMD) for height-age showed an increase in the MP-LSW and MP-VLD groups (p < 0.01). Our data suggest that MP-LSW and MP-VLD strategies improve linear growth, BMD, the peripheral distribution of fat, and preservation of the bone-muscle unit and maintain the normal lipid profile. The MP-LSW patients had a concerning rate of acute rejections and graft function deterioration in prepubertal patients.

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Pediatric renal transplantation with mycophenolate mofetil-based immunosuppression without induction: results after three years1,2

Abstract: These results suggest that MMF is safe and beneficial as a longer term maintenance immunosuppressive drug in children and adolescents.

Cited by 64 publications

References 28 publications

Enteric-coated mycophenolate sodium in de novo pediatric renal transplant patients

Enteric-coated mycophenolate sodium in de novo pediatric renal transplant patients

Consensus Report on Therapeutic Drug Monitoring of Mycophenolic Acid in Solid Organ Transplantation

A study on strategies for improving growth and body composition after renal transplantation

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