{"id":"mycophenolate-to-sirolimus-switch","safety":{"commonSideEffects":[{"rate":null,"effect":"Hyperlipidemia"},{"rate":null,"effect":"Thrombocytopenia"},{"rate":null,"effect":"Delayed wound healing"},{"rate":null,"effect":"Mouth ulcers"},{"rate":null,"effect":"Pneumonitis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This represents a clinical protocol switch from mycophenolate (an inosine monophosphate dehydrogenase inhibitor that suppresses T and B cell proliferation) to sirolimus (an mTOR inhibitor with anti-proliferative and immunomodulatory effects). The switch aims to optimize long-term immunosuppressive therapy by leveraging sirolimus's distinct mechanism and potentially improved safety profile in certain transplant populations.","oneSentence":"A therapeutic strategy that replaces mycophenolate mofetil with sirolimus to reduce immunosuppressive burden while maintaining graft protection in transplant recipients.","_ai_confidence":"low"},"_scrapedAt":"2026-03-27T23:56:20.779Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Organ transplant recipients (kidney, heart, liver) requiring immunosuppressive therapy optimization"}]},"trialDetails":[{"nctId":"NCT04104438","phase":"PHASE4","title":"Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant","status":"COMPLETED","sponsor":"Fady M Kaldas, M.D., F.A.C.S.","startDate":"2021-01-15","conditions":"Asses Immunosuppression Modulation on Renal Recovery Post LT","enrollment":71},{"nctId":"NCT06504225","phase":"","title":"EVEROLD LONG TERM FOLLOW-UP","status":"RECRUITING","sponsor":"University Hospital, Brest","startDate":"2024-08-23","conditions":"Transplant; Complication, Failure","enrollment":260},{"nctId":"NCT04066114","phase":"PHASE1, PHASE2","title":"Treg Modulation With CD28 and IL-6 Receptor Antagonists","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2019-12-11","conditions":"Living-Donor Kidney Transplant, Kidney Transplant Recipients","enrollment":24},{"nctId":"NCT04936971","phase":"PHASE4","title":"Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response","status":"WITHDRAWN","sponsor":"Edoardo Melilli","startDate":"2021-09","conditions":"Kidney Transplantation, Cytomegalovirus Infections","enrollment":""},{"nctId":"NCT00866879","phase":"PHASE4","title":"Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients","status":"COMPLETED","sponsor":"Northwestern University","startDate":"2007-06","conditions":"Renal Transplant Rejection","enrollment":275},{"nctId":"NCT00223678","phase":"PHASE4","title":"Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure","status":"COMPLETED","sponsor":"Vanderbilt University Medical Center","startDate":"2000-06","conditions":"Kidney Transplant","enrollment":20},{"nctId":"NCT01134952","phase":"PHASE4","title":"Study of Sirolimus Versus Mycophenolate Liver Transplant Recipients With Recurrent Hepatitis C Virus (HCV)","status":"COMPLETED","sponsor":"London Health Sciences Centre","startDate":"2010-06","conditions":"Hepatitis C","enrollment":11},{"nctId":"NCT01028092","phase":"PHASE3","title":"mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation","status":"COMPLETED","sponsor":"University Hospital, Brest","startDate":"2009-03","conditions":"Renal Transplant","enrollment":327},{"nctId":"NCT00956293","phase":"PHASE4","title":"Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2009-07","conditions":"Renal Transplantation","enrollment":207},{"nctId":"NCT01455649","phase":"PHASE4","title":"Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After Kidney Transplantation in Adults","status":"UNKNOWN","sponsor":"Deise de Boni Monteiro de Carvalho","startDate":"2011-11","conditions":"Kidney Transplant, Immunosuppression","enrollment":30}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["rapamune","rapamycin","mycophenolic mofetil","mycophenolic acid","cellcept"],"phase":"marketed","status":"active","brandName":"Mycophenolate to sirolimus switch","genericName":"Mycophenolate to sirolimus switch","companyName":"London Health Sciences Centre","companyId":"london-health-sciences-centre","modality":"Small molecule","firstApprovalDate":"","aiSummary":"A therapeutic strategy that switches patients from mycophenolate mofetil (an inosine monophosphate dehydrogenase inhibitor) to sirolimus (an mTOR inhibitor) to optimize immunosuppression in transplant recipients. Used for Organ transplant rejection prevention (switch strategy in transplant recipients).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}