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PLoS One. 2015 Sep 25;10(9):e0135439. doi: 10.1371/journal.pone.0135439. eCollection 2015.

Efficacy and Safety of an Everolimus- vs. a Mycophenolate Mofetil-Based Regimen in Pediatric Renal Transplant Recipients.

Author information

1
Department of Pediatric Nephrology, Hannover Medical School, Hannover, Germany.
2
Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.
3
Department of Pediatric Nephrology, Hannover Medical School, Hannover, Germany; Department of Visceral and Transplant Surgery, University Hospital of Schleswig-Holstein, Kiel, Germany.
4
Department of Pediatric Nephrology, Olgahospital, Stuttgart, Germany.
5
Department of Biostatistics, University Clinic of Göttingen, Göttingen, Germany.

Abstract

INTRODUCTION:

Data on the efficacy and safety of everolimus in pediatric renal transplantation compared to other immunosuppressive regimens are scarce.

PATIENTS/METHODS:

We therefore performed a multicenter, observational, matched cohort study over 4 years post-transplant in 35 patients on everolimus plus low-dose cyclosporine, who were matched (1:2) with a control group of 70 children receiving a standard-dose calcineurin-inhibitor- and mycophenolate mofetil-based regimen.

RESULTS:

Corticosteroids were withdrawn in 83% in the everolimus vs. 39% in the control group (p<0.001). Patient and graft survival were comparable. The rate of biopsy-proven acute rejection episodes Banff score ≥ IA during the first year post-transplant was 6% in the everolimus vs. 13% in the control group (p = 0.23). The rate of de novo donor-specific HLA antibodies (11% in everolimus, 18% in controls) was comparable (p = 0.55). At 4 years post-transplant, mean eGFR in the everolimus group was 56±33 ml/min per 1.73 m² vs. 63±22 ml/min per 1.73 m² in the control group (p = 0.14). Everolimus therapy was associated with less BK polyomavirus replication (3% vs. 17% in controls; p = 0.04), but with a higher percentage of arterial hypertension and more hyperlipidemia (p<0.001).

CONCLUSION:

In pediatric renal transplantation, an everolimus-based regimen with low-dose cyclosporine yields comparable four year results as a standard regimen, but with a different side effect profile.

PMID:
26407177
PMCID:
PMC4583261
DOI:
10.1371/journal.pone.0135439
[Indexed for MEDLINE]
Free PMC Article

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