Fixed low dose versus concentration-controlled initial tacrolimus dosing with reduced target levels in the course after kidney transplantation: results from a prospective randomized controlled non-inferiority trial (slow & low study)
Background - Optimal initial tacrolimus dosing and early exposure of tacrolimus after renal transplantation is not well studied. - Methods - In this open-label, 6 months, multicenter, randomized controlled, non-inferiority study, we randomly assigned 432 renal allograft recipients to receive basilix...
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| Hauptverfasser: | , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
January 2024
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| In: |
EClinicalMedicine
Year: 2024, Jahrgang: 67, Pages: 1-15 |
| ISSN: | 2589-5370 |
| DOI: | 10.1016/j.eclinm.2023.102381 |
| Online-Zugang: | Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.eclinm.2023.102381 Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S2589537023005588 
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| Verfasserangaben: | Julian Stumpf, Klemens Budde, Oliver Witzke, Claudia Sommerer, Thomas Vogel, Peter Schenker, Rainer Peter Woitas, Mirian Opgenoorth, Evelyn Trips, Eva Schrezenmeier, and Christian Hugo, German S&L Study |
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| 245 | 1 | 0 | |a Fixed low dose versus concentration-controlled initial tacrolimus dosing with reduced target levels in the course after kidney transplantation |b results from a prospective randomized controlled non-inferiority trial (slow & low study) |c Julian Stumpf, Klemens Budde, Oliver Witzke, Claudia Sommerer, Thomas Vogel, Peter Schenker, Rainer Peter Woitas, Mirian Opgenoorth, Evelyn Trips, Eva Schrezenmeier, and Christian Hugo, German S&L Study |
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| 520 | |a Background - Optimal initial tacrolimus dosing and early exposure of tacrolimus after renal transplantation is not well studied. - Methods - In this open-label, 6 months, multicenter, randomized controlled, non-inferiority study, we randomly assigned 432 renal allograft recipients to receive basiliximab induction, mycophenolate and steroids and either standard prolonged-release tacrolimus (trough levels: 7-9 ng/ml; Standard Care arm), or an initial 7-day fixed 5 mg/day dose of prolonged-release tacrolimus followed by lower tacrolimus predose levels (trough levels: 5-7 ng/ml; Slow & Low arm). The primary end point was the combined incidence rate of biopsy-proven acute rejections (BPAR; including borderline), graft failure, or death at 6 months with a non-inferiority margin of 12.5%. (EudraCT-Nr: 2013-001770-19. - Findings - The combined primary endpoint in the Slow & Low arm was non-inferior compared to the Standard Care arm (22.1% versus 20.7%; difference: 1.4%, 90% CI −5.5% to 8.3%). The overall rate of BPAR including borderlines was similar (Slow & Low 17.4% versus Standard Care 16.6%). Safety parameters such as delayed graft function, kidney function, donor specific HLA-antibodies, infections, or post-transplantation diabetes mellitus did not differ. - Interpretation - This is the first study to show that an initial fixed dose of 5 mg per day followed by lower tacrolimus exposure is non-inferior compared to standard tacrolimus therapy and equally efficient and safe within 6 months after renal transplantation. These data suggest that therapeutic drug monitoring for prolonged release tacrolimus can be abandoned until start of the second week after transplantation. - Funding - Investigator-initiated trial, financial support by Astellas Pharma GmbH. | ||
| 650 | 4 | |a Fixed low dose | |
| 650 | 4 | |a Immunosuppression | |
| 650 | 4 | |a Renal transplantation | |
| 650 | 4 | |a Tacrolimus monitoring | |
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| 700 | 1 | |a Witzke, Oliver |e VerfasserIn |4 aut | |
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| 700 | 1 | |a Lopau, Kai |e VerfasserIn |4 aut | |
| 700 | 1 | |a Lutz, Jens |e VerfasserIn |4 aut | |
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