A randomized, controlled trial of everolimus-based dual immunosuppression versus standard of care in de novo kidney transplant recipients
| Autor: | Steven J, Chadban, Josette Marie, Eris, John, Kanellis, Helen, Pilmore, Po Chang, Lee, Soo Kun, Lim, Chad, Woodcock, Nicol, Kurstjens, Graeme, Russ, Steffen, Witte |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Male medicine.medical_specialty medicine.medical_treatment Calcineurin Inhibitors Urology kidney transplantation Pharmacology Mycophenolate Mycophenolic acid law.invention Young Adult Randomized controlled trial law Adrenal Cortex Hormones Transplantation Immunology Clinical Research medicine Humans Everolimus Prospective Studies Kidney transplantation Aged mammalian target of rapamycin Immunosuppression Therapy Sirolimus Transplantation business.industry TOR Serine-Threonine Kinases Immunosuppression Standard of Care Middle Aged Mycophenolic Acid medicine.disease cyclosporin Calcineurin Treatment Outcome Cyclosporine Female business Immunosuppressive Agents medicine.drug Glomerular Filtration Rate steroids |
| Zdroj: | Transplant International |
| ISSN: | 1432-2277 |
| Popis: | Kidney transplant recipients receiving calcineurin inhibitor-based immunosuppression incur increased long-term risks of cancer and kidney fibrosis. Switch to mammalian target of rapamycin (mTOR) inhibitors may reduce these risks. Steroid or Cyclosporin Removal After Transplant using Everolimus (SOCRATES), a 36-month, prospective, multinational, open-label, randomized controlled trial for de novo kidney transplant recipients, assessed whether everolimus switch could enable elimination of mycophenolate plus either steroids or CNI without compromising efficacy. Patients received cyclosporin, mycophenolate and steroids for the first 14 days then everolimus with mycophenolate and CNIwithdrawal (CNI-WD); everolimus with mycophenolate and steroid withdrawal (steroid-WD); or cyclosporin, mycophenolate and steroids (control). 126 patients were randomized. The steroid WD arm was terminated prematurely because of excess discontinuations. Mean eGFR at month 12 for CNI-WD versus control was 65.1 ml/min/1.73 m2 vs. 67.1 ml/min/1.73 m2 by ITT, which met predefined noninferiority criteria (P = 0.026). The CNI-WD group experienced a higher rate of BPAR(31% vs. control 13%, P = 0.048) and showed a trend towards higher composite treatment failure (BPAR, graft loss, death, loss to follow-up). The 12 month results from SOCRATES show noninferiority in eGFR, but a significant excess of acute rejection when everolimus was commenced at week 2 to enable a progressive withdrawal of mycophenolate and cyclosporin in kidney transplant recipients. |
| Databáze: | OpenAIRE |
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