3. The ASCERTAIN Study. Source Holdaas H, Rostaing L, Serón D, et al. Conversion of long-term...
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Transcript of 3. The ASCERTAIN Study. Source Holdaas H, Rostaing L, Serón D, et al. Conversion of long-term...
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3. The ASCERTAIN Study3. The ASCERTAIN Study
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3. The ASCERTAIN Study3. The ASCERTAIN Study
Source
Holdaas H, Rostaing L, Serón D, et al. Conversion of long-term kidney transplant recipients from calcineurin inhibitor therapy to everolimus: a randomized, multicenter, 24-month study. Transplantation. 2011;92(4):410–418.
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Background
Calcineurin inhibitor (CNI) therapy is known to induce nephrotoxicity in a dose-dependent manner. Nevertheless, improvements in graft function following elimination or reduction of CNI exposure in long-term kidney transplant recipients remains unclear. Furthermore, benefits of conversion from CNI to mammalian target of rapamycin inhibitor-based immunosuppression in long-term kidney transplant patients remain uncertain. The current study addressed this hypothesis.
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Aim
The ASCERTAIN study was undertaken to determine improvements in graft function in renal transplant patients with renal impairment following introduction of everolimus with elimination or minimization of CNI.
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Methods
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Key results
• Differences between CNI elimination (1.12 mL/min/1.73 m2, 95% confidence interval [CI]: -3.51 to 5.76, P=0.63) and CNI minimization (0.59 mL/min/1.73 m2, 95% CI: -3.88 to 5.07, P=0.79) vs controls at month 24 were non-significant.• Post hoc analyses showed that patients with baseline creatinine clearance more than 50 mL/min had a significantly greater increase in measured GFR after CNI elimination vs controls.• Adverse events resulted in discontinuation in 36 (28.3%) CNI elimination patients, 24 (16.7%) CNI minimization patients, and 5 (4.1%) controls (P<0.001 vs CNI elimination; P=0.020 vs CNI minimization).
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Conclusion
• Conversion to everolimus with CNI elimination or minimization had no overall renal benefit and was associated with more frequent adverse events and discontinuations.• Patients with a creatinine clearance of more than 50 mL/min may benefit from a change in therapy administered 6 months after renal transplantation.
Conversion to everolimus with CNI elimination or minimization had no overall renal benefit.