Русский
The use of Everolimus as a part of maintenance immunosuppressive therapy in patients with minimal renal transplant dysfunction: results of a prospective observational program (crad001aru01)
E.I. Prokopenko, E.S. Stolyarevich
Aim. To evaluate the safety, tolerability and effectiveness of everolimus in adult renal transplant recipients with minimal manifestations of renal allograft (RAG) dysfunction and to assess the dynamics of the graft function.
Material and methods. This prospective observational study comprised 45 adult patients (27 men and 18 women) from 9 Russian centers 4–60 months after renal transplantation with a low immunological risk and minimal graft dysfunction. Following enrollment in the study, the patient immunosuppression was converted from full-dose cyclosporine A (CsA), mycophenolate, and corticosteroids (CS) to everolimus, CS and the reduced dose of CsA. Twelve months follow-up included estimation of clinical and biochemical parameters, glomerular filtration rate (GFR), C0-blood concentration of CsA and everolimus, and registration of adverse events.
Results. All patients were alive at the end of the study. RAG rejection rate was 6.7%. One patient lost the graft from severe rejection. The mean level of serum creatinine remained stable – 161.0±5.2 mmol/l at baseline and 160.5±8.6 mmol/l at 12 months, p=0,69. Baseline calculated GFR was 52.8±2.1 ml/min, and 53.9±2.3 ml/min at 12 months, p=0.15. Mean C0-concentration of CsA significantly decreased from 79.0±5.6 ng/ml at day 4–5 after the everolimus administration to 49.0±4.5 ng/ml at 12 months, p<0.001. A significant reduction in systolic blood pressure from 131.4±1.7 to 127.1±1.8 mmHg (p=0.01) was observed.
Conclusion. Immunosuppression using everolimus concurrently with CS and reduced dose of CsA for 12 months was effective and safe in RAG recipients with low immunological risk. Apparently, such treatment may help inhibit chronic transplant nephropathy in the absence of rejection, but this has to be proven in further randomized trials.
Material and methods. This prospective observational study comprised 45 adult patients (27 men and 18 women) from 9 Russian centers 4–60 months after renal transplantation with a low immunological risk and minimal graft dysfunction. Following enrollment in the study, the patient immunosuppression was converted from full-dose cyclosporine A (CsA), mycophenolate, and corticosteroids (CS) to everolimus, CS and the reduced dose of CsA. Twelve months follow-up included estimation of clinical and biochemical parameters, glomerular filtration rate (GFR), C0-blood concentration of CsA and everolimus, and registration of adverse events.
Results. All patients were alive at the end of the study. RAG rejection rate was 6.7%. One patient lost the graft from severe rejection. The mean level of serum creatinine remained stable – 161.0±5.2 mmol/l at baseline and 160.5±8.6 mmol/l at 12 months, p=0,69. Baseline calculated GFR was 52.8±2.1 ml/min, and 53.9±2.3 ml/min at 12 months, p=0.15. Mean C0-concentration of CsA significantly decreased from 79.0±5.6 ng/ml at day 4–5 after the everolimus administration to 49.0±4.5 ng/ml at 12 months, p<0.001. A significant reduction in systolic blood pressure from 131.4±1.7 to 127.1±1.8 mmHg (p=0.01) was observed.
Conclusion. Immunosuppression using everolimus concurrently with CS and reduced dose of CsA for 12 months was effective and safe in RAG recipients with low immunological risk. Apparently, such treatment may help inhibit chronic transplant nephropathy in the absence of rejection, but this has to be proven in further randomized trials.
Keywords: renal graft dysfunction, m-TOR inhibitors, immunosuppression, everolimus, renal transplantation
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