{"id":"prophylaxis-with-valganciclovir-plus-mycophenolate","safety":{"commonSideEffects":[{"rate":null,"effect":"Neutropenia"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Renal impairment"},{"rate":null,"effect":"Infection (non-CMV)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Valganciclovir is a nucleoside analog that inhibits CMV DNA polymerase, preventing viral replication in transplant recipients. Mycophenolate is an inosine monophosphate dehydrogenase (IMPDH) inhibitor that selectively suppresses T and B lymphocyte proliferation. Together, they provide both CMV prophylaxis and immunosuppression to prevent graft rejection in transplant patients.","oneSentence":"This combination prophylaxis regimen suppresses cytomegalovirus (CMV) replication while simultaneously reducing T-cell mediated rejection through dual immunosuppressive and antiviral mechanisms.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:30:32.353Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"CMV prophylaxis and rejection prevention in solid organ transplant recipients"}]},"trialDetails":[{"nctId":"NCT07430683","phase":"PHASE4","title":"Valganciclovir Prophylaxis Versus Preemptive Therapy for Cytomegalovirus in Living Donor Kidney Transplant Recipients","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Guadalajara","startDate":"2024-03-01","conditions":"Cytomegalovirus Infections","enrollment":68},{"nctId":"NCT07203664","phase":"PHASE4","title":"Use of Tacrolimus and MTOR Inhibitors With Anticipatory Therapy vs. Tacrolimus and Mycophenolic Acid With Universal Prophylaxis in Renal Recipients at High Risk of Posttransplant Cytomegalovirus.","status":"NOT_YET_RECRUITING","sponsor":"Hospital Universitario La Paz","startDate":"2025-10-30","conditions":"Evaluate the Effectiveness of CMV Prevention Strategies in Kidney Transplant Recipients","enrollment":30},{"nctId":"NCT02188719","phase":"PHASE1","title":"Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation","status":"TERMINATED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2014-12-17","conditions":"Liver Transplantation","enrollment":15},{"nctId":"NCT00141037","phase":"PHASE1, PHASE2","title":"Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2004-03","conditions":"Kidney Diseases, Kidney Transplantation, Kidney Transplant","enrollment":130},{"nctId":"NCT00966836","phase":"PHASE3","title":"Prevention of Transplant Atherosclerosis With Everolimus and Anti-cytomegalovirus Therapy","status":"UNKNOWN","sponsor":"University of Bologna","startDate":"2009-04","conditions":"Heart Transplantation, Cardiac Allograft Vasculopathy, Cytomegalovirus Infection","enrollment":100}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Prophylaxis with valganciclovir plus mycophenolate","genericName":"Prophylaxis with valganciclovir plus mycophenolate","companyName":"University of Bologna","companyId":"university-of-bologna","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination prophylaxis regimen suppresses cytomegalovirus (CMV) replication while simultaneously reducing T-cell mediated rejection through dual immunosuppressive and antiviral mechanisms. Used for CMV prophylaxis and rejection prevention in solid organ transplant recipients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}