{"id":"arm-1-everolimus-reduced-dose-tacrolimus","safety":{"commonSideEffects":[{"rate":null,"effect":"Infection"},{"rate":null,"effect":"Hyperglycemia"},{"rate":null,"effect":"Hyperlipidemia"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Thrombocytopenia"},{"rate":null,"effect":"Renal dysfunction"},{"rate":null,"effect":"Mouth ulcers"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Everolimus is an mTOR inhibitor that suppresses proliferation of T cells and B cells by blocking nutrient sensing pathways. Tacrolimus is a calcineurin inhibitor that prevents IL-2 production and T-cell activation. This combination regimen uses lower tacrolimus doses to reduce nephrotoxicity and other calcineurin-related toxicities while maintaining immunosuppressive efficacy through dual mechanism inhibition.","oneSentence":"Everolimus inhibits mTOR signaling to suppress immune cell proliferation, while reduced-dose tacrolimus inhibits calcineurin to prevent T-cell activation, together reducing organ rejection risk in transplant recipients.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:18:09.473Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Organ transplant rejection prophylaxis (renal transplantation)"}]},"trialDetails":[{"nctId":"NCT06552169","phase":"PHASE2","title":"REgulatory T Cell Therapy to Achieve Immunosuppression REduction","status":"RECRUITING","sponsor":"Singulera Therapeutics Inc.","startDate":"2025-06-13","conditions":"Kidney Transplantation","enrollment":34},{"nctId":"NCT03468478","phase":"PHASE4","title":"Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation","status":"COMPLETED","sponsor":"Hospital do Rim e Hipertensão","startDate":"2017-06-18","conditions":"Kidney Transplant Infection","enrollment":1209},{"nctId":"NCT01935128","phase":"PHASE4","title":"Evaluation of Calcineurin-inhibitor Reduction With Conversion at 2 Months to Everolimus/Reduced Tacrolimus in Renal Transplant Recipients Following Campath® Induction","status":"COMPLETED","sponsor":"University of Toledo Health Science Campus","startDate":"2013-07-03","conditions":"Renal Transplant","enrollment":55},{"nctId":"NCT01653847","phase":"NA","title":"Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens","status":"COMPLETED","sponsor":"Northwestern University","startDate":"2013-02","conditions":"End Stage Renal Failure With Renal Transplant","enrollment":88},{"nctId":"NCT00377962","phase":"PHASE4","title":"Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2005-12","conditions":"Disorder Related to Cardiac Transplantation","enrollment":282},{"nctId":"NCT01473732","phase":"NA","title":"Mechanisms and Treatment of Chronic Allograft Injury (CAI) Due to Calcineurin Inhibitor (CNI) Toxicity","status":"TERMINATED","sponsor":"Montefiore Medical Center","startDate":"2012-03","conditions":"Chronic Allograft Injury, Calcineurin Inhibitor Toxicity","enrollment":2},{"nctId":"NCT01598987","phase":"PHASE3","title":"Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-10","conditions":"Renal Function, Liver Transplant","enrollment":56},{"nctId":"NCT01624948","phase":"PHASE4","title":"Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2012-09","conditions":"BK Virus Infection","enrollment":40},{"nctId":"NCT01625377","phase":"PHASE3","title":"A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-12","conditions":"Liver Transplantation","enrollment":188},{"nctId":"NCT01025817","phase":"PHASE3","title":"Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2010-01","conditions":"Kidney Transplant","enrollment":613}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Zortress®","Prograf® or Hecoria®"],"phase":"marketed","status":"active","brandName":"Arm 1 Everolimus/Reduced dose tacrolimus","genericName":"Arm 1 Everolimus/Reduced dose tacrolimus","companyName":"University of Toledo Health Science Campus","companyId":"university-of-toledo-health-science-campus","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Everolimus inhibits mTOR signaling to suppress immune cell proliferation, while reduced-dose tacrolimus inhibits calcineurin to prevent T-cell activation, together reducing organ rejection risk in transplant recipients. Used for Organ transplant rejection prophylaxis (renal transplantation).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}