Early conversion of pediatric kidney transplant patients to everolimus with reduced tacrolimus and steroid elimination: results of a randomized trial
In a 12-month, multicenter, open-label study, 106 children were randomized at 4 to 6 weeks after kidney transplantation to switch to everolimus with reduced TAC (EVR/rTAC) and steroid elimination from month 5 posttransplant or to continue standard tacrolimus with mycophenolate mofetil (sTAC/MMF) and...
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| Main Author: | |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2019
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| In: |
American journal of transplantation
Year: 2018, Volume: 19, Issue: 3, Pages: 811-822 |
| ISSN: | 1600-6143 |
| DOI: | 10.1111/ajt.15081 |
| Online Access: | Verlag, Volltext: https://doi.org/10.1111/ajt.15081
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| Author Notes: | Burkhard Toenshoff, Robert Ettenger, Luca Dello Strologo, Stephen D. Marks, Lars Pape, Helio Tedesco-Silva Jr, Anna Bjerre, Martin Christian, Matthias Meier, El-Djouher Martzloff, Barbara Rauer, Jennifer Ng, Patricia Lopez |
| Summary: | In a 12-month, multicenter, open-label study, 106 children were randomized at 4 to 6 weeks after kidney transplantation to switch to everolimus with reduced TAC (EVR/rTAC) and steroid elimination from month 5 posttransplant or to continue standard tacrolimus with mycophenolate mofetil (sTAC/MMF) and steroids. The cumulative incidence of a co-primary efficacy end point (biopsy-proven acute rejection [BPAR], graft loss, or death from randomization to month 12) was 10.3% with EVR/rTAC and 5.8% with sTAC/MMF (difference 4.4%; P = .417). BPAR occurred in 9.6% and 5.6% of patients, respectively. Patient and renal allograft survival were 100%. The co-primary end point of mean estimated glomerular filtration rate at month 12 was 76.2 mL/min/1.73 m(2) with EVR/rTAC and 72.5 mL/min/1.73 m(2) for sTAC/MMF (difference 3.8 mL/min/1.73m(2); P = .49). One EVR/rTAC patient developed posttransplant lymphoproliferative disease. Longitudinal growth and sexual maturation were equivalent between groups. The randomized drug regimen was discontinued in 34.6% and 13% of patients in the EVR/rTAC and sTAC/MMF groups, respectively (P = .024), and discontinued due to adverse events/infections in 25.0% and 11.1% of patients (P = .062). In conclusion, early conversion of pediatric kidney transplant patients from TAC, MMF, and steroids to EVR/rTAC and steroid withdrawal maintains immunosuppressive efficacy and preserves renal function. |
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| Item Description: | First published: 20 August 2018 Gesehen am 04.04.2019 |
| Physical Description: | Online Resource |
| ISSN: | 1600-6143 |
| DOI: | 10.1111/ajt.15081 |