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Mycophenolate mofetil-based immunosuppression with sirolimus in renal transplantation: a randomized, controlled Spare-the-Nephron trial
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Mycophenolate mofetil-based immunosuppression with sirolimus in renal transplantation: a randomized, controlled Spare-the-Nephron trial
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Mycophenolate mofetil-based immunosuppression with sirolimus in renal transplantation: a randomized, controlled Spare-the-Nephron trial
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Journal Article
Mycophenolate mofetil-based immunosuppression with sirolimus in renal transplantation: a randomized, controlled Spare-the-Nephron trial
2011
Overview
As part of the Spare-the-Nephron trial, we evaluated the combination mycophenolate mofetil (MMF) and sirolimus (SRL) as a calcineurin inhibitor (CNI)-free regimen for the preservation of renal function in renal allograft recipients. This 2-year, open-label, multicenter trial randomized 299 patients of which 151 were maintained on MMF and a CNI, 148 on MMF plus SRL (n=120, tacrolimus; n=31, cyclosporine). Baseline characteristics including measured (iothalamate) glomerular filtration rate (GFR) were similar between groups. After 1 year, the mean percentage change from baseline in the primary end point of measured GFR was significantly higher in the MMF/SRL group compared with the MMF/CNI group. After 2 years, the change was indistinguishable. Calculated creatinine clearance and GFR were significantly greater with MMF/SRL at 2 years within which biopsy-proven acute rejection (BPAR) occurred in 14 MMF/SRL-treated patients (3 graft losses) and in 17 receiving the MMF/CNI (6 graft losses). Significantly, no patients receiving MMF/SRL but five treated with MMF/CNI died. Thus, compared with MMF/CNI treatment, a 2-year regimen of MMF/SRL resulted in similar measures of renal function but with fewer deaths and a trend to less BPAR and graft loss.
Publisher
Elsevier Inc,Nature Publishing Group,Elsevier Limited
Subject
/ Adult
/ Aged
/ Biological and medical sciences
/ Female
/ Glomerular Filtration Rate - drug effects
/ Graft Rejection - prevention & control
/ Humans
/ Immunosuppressive Agents - administration & dosage
/ Immunosuppressive Agents - adverse effects
/ Kidney Transplantation - adverse effects
/ Kidney Transplantation - methods
/ Kidney Transplantation - physiology
/ Male
/ Mycophenolic Acid - administration & dosage
/ Mycophenolic Acid - adverse effects
/ Mycophenolic Acid - analogs & derivatives
/ Nephrology. Urinary tract diseases
