[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07571135":3,"trial-entities:NCT07571135":107,"trial-summary:NCT07571135":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":46,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":78,"locations":81,"central_contacts":101,"overall_officials":104,"references":105,"see_also_links":106},"NCT07571135","STUDY00000831","Letermovir vs Valganciclovir in CMV R+ Kidney Transplant","Letermovir Versus Valganciclovir for 90 Days in CMV Seropositive Kidney Transplant Recipients: Results of a Single-center Experience.","NOT_YET_RECRUITING","2028-11","2026-03","2026-05-08","2026-05","Elisabeth Kincaide","OTHER_GOV",false,"The purpose of this study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir (\"mini dose\"). Both groups will be on CMV prophylaxis drug for 90 days post-transplant.\n\nThe main question the study wants to answer is:\n\n• Does letermovir work as well as valganciclovir in preventing CMV infections during the first 12 months after a kidney transplant?\n\nThe study will also look at other important questions:\n\n* Is letermovir easier for patients to tolerate than valganciclovir?\n* How long does it take for a CMV infection to appear in each group?\n* Are there differences in \"breakthrough\" CMV infections between the two medications?\n* For patients who develop CMV that becomes resistant to treatment, are the resistance patterns different between the two groups","The purpose of this study is to evaluate the efficacy and tolerability of letermovir compared to standard-of-care, valganciclovir, for the prevention of clinically significant cytomegalovirus (CMV) infection in CMV moderate risk adult kidney transplant recipients.\n\nA 3:1 match of historical valganciclvoir:letermovir arm\n\n• Matching criteria:\n\n* Induction agent: lymphocyte-depleting (rabbit anti-thymocyte globulin or alemtuzumab) versus non-lymphocyte depleting (basiliximab)\n* Delayed graft function (dialysis within one week of kidney transplant)\n* MMF dose at de novo discharge (weight-based vs non-weight based)\n\nStudy Arms:\n\n* Letermovir Arm:\n\n  * Letermovir 480 mg PO daily starting POD 4 through 10 OR\n  * Letermovir 240 mg PO daily if given concomitantly with cyclosporine, for 90 days\n  * Will be given with acyclovir 400 mg PO BID (or 200 PO BID if CrCl \\\u003C25) for 90 days\n* Historical Arm:\n\n  * Valganciclovir 450 mg PO daily (adjusted for renal function) for 90 days\n\n    * CrCl 25-30: valganciclovir 450 mg PO q 48 h\n    * CrCl \\\u003C25: Valganciclovir 450 mg PO three times weekly\n\nOutcomes:\n\n* Primary Efficacy Objective:\n\n  * Incidence of patients with clinically significant CMV infection at 12 months post kidney transplant in patients who received letermovir versus standard of care valganciclovir\n\n    * Clinically Significant CMV Infection: CMV disease or symptomatic viremia requiring therapeutic intervention\n* Secondary Objectives:\n\n  * Tolerability:\n\n    * Proportion of patients with leukopenia or neutropenia (composite) in patients who received letermovir versus standard of care valganciclovir\n* Leukopenia: white blood cells \\\u003C 3500 cells\u002FuL\n* Neutropenia: absolute neutrophil count \\\u003C 1000 cells\u002FuL\n\n  * Intolerability or early drug discontinuation\n* Proportion of patients who discontinue the study drug prematurely due to adverse events or intolerance\n\n  o Efficacy:\n  * Time-to clinically significant CMV infection (days)\n  * Breakthrough CMV while on CMV prophylaxis\n* CMV Viremia\n\n  * Detection of CMV DNA in blood via PCR\n* Clinically significant CMV infection\n\n  * CMV resistance\n* Detection of CMV strains with genotypic or phenotypic resistance to antiviral agents used in prophylaxis or treatment",[19,20,21,22],"CMV Infection","CMV","CMV Viremia","CMV Disease",[20,24,25,26,27,28,29],"Kidney Transplant","Letermovir","Moderate Risk","CMV Prophylaxis","Valganciclovir","Neutropenia","INTERVENTIONAL","PREVENTION",[33],"PHASE4",{"count":35,"type":36},300,"ESTIMATED",[38,42],{"type":39,"name":25,"description":40,"armGroupLabels":41},"DRUG","Letermovir 480 mg PO daily or 240 mg PO daily (if on cyclosporine) for 90 days post kidney transplant",[25],{"type":39,"name":43,"description":44,"armGroupLabels":45},"Valganciclovir CMV Prophylaxis","Valganciclovir 450 mg PO daily for 90 days post kidney transplant (Historical Control)",[28],[47],{"measure":19,"description":48,"timeFrame":49},"Incidence of patients with clinically significant CMV infection at 12 months post kidney transplant in patients who received letermovir versus standard of care valganciclovir.","12 months post kidney transplant",[],"ALL","18 Years",null,{"inclusion":55,"exclusion":60,"raw_text":77},[56,57,58,59],"≥18 years old","Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant","Males agree to use contraception and refraining from donating sperm for 290 days post-treatment initiation","Females of child-bearing potential agree to follow contraception guidance for 290 days post-treatment initiation",[61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"Multiorgan organ transplant","Received previous solid organ transplant or HSCT","Unable to take oral medications","Uncontrolled infections at the time of enrollment","Hemodynamically unstable or on mechanical ventilation at the time of enrollment","Documented HBsAg or detectable HCV RNA 90 days prior to enrollment or HCV+ donor","Pregnant or breastfeeding or planning to be pregnant, breastfeeding or donating eggs during study period and 90 days post cessation","Received any anti-CMV drug treatment within 7 days prior to enrollment","Current user of recreational or illicit drugs or alcohol dependence","History of CMV disease prior to enrollment","Previously participated in a letermovir study or any other study with CMV investigational agents","On dialysis or plasmapheresis at the time of enrollment","Known or suspected hypersensitivity to active or inactive ingredients from letermovir or acyclovir formulations","Child-Pugh Class C severe hepatic insufficiency","Currently participating or has participated in a study with an unapproved compound of device within 28 days or 5 half-lives of this study","Contraindications per letermovir or acyclovir package insert: patients on pimozide, ergot alkaloids; or pitavastatin and simvastatin when co-administered with cyclosporine","Inclusion Criteria (both arms):\n\n* ≥18 years old\n* Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant\n\nInclusion Criteria (letermovir arm):\n\n* Males agree to use contraception and refraining from donating sperm for 290 days post-treatment initiation\n* Females of child-bearing potential agree to follow contraception guidance for 290 days post-treatment initiation\n\nExclusion Criteria (both arms):\n\n* Multiorgan organ transplant\n* Received previous solid organ transplant or HSCT\n* Unable to take oral medications\n* Uncontrolled infections at the time of enrollment\n* Hemodynamically unstable or on mechanical ventilation at the time of enrollment\n* Documented HBsAg or detectable HCV RNA 90 days prior to enrollment or HCV+ donor\n* Pregnant or breastfeeding or planning to be pregnant, breastfeeding or donating eggs during study period and 90 days post cessation\n* Received any anti-CMV drug treatment within 7 days prior to enrollment\n* Current user of recreational or illicit drugs or alcohol dependence\n* History of CMV disease prior to enrollment\n\nExclusion Criteria (letermovir arm):\n\n* Previously participated in a letermovir study or any other study with CMV investigational agents\n* On dialysis or plasmapheresis at the time of enrollment\n* Known or suspected hypersensitivity to active or inactive ingredients from letermovir or acyclovir formulations\n* Child-Pugh Class C severe hepatic insufficiency\n* Currently participating or has participated in a study with an unapproved compound of device within 28 days or 5 half-lives of this study\n* Contraindications per letermovir or acyclovir package insert: patients on pimozide, ergot alkaloids; or pitavastatin and simvastatin when co-administered with cyclosporine",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":98},"University Hospital","San Antonio","Texas","78229","United States",[89,94],{"name":90,"role":91,"phone":92,"email":93},"Elisabeth Kincaide, PharmD","CONTACT","210-743-4086","Elisabeth.Kincaide@uhtx.com",{"name":95,"role":91,"phone":96,"email":97},"Sean Moore, BSN, RN","210-475-2559","Sean.Moore2@uhtx.com",{"lat":99,"lon":100},29.42412,-98.49363,[102,103],{"name":90,"role":91,"phone":92,"email":93},{"name":95,"role":91,"phone":96,"email":97},[],[],[],{"nct_id":4,"conditions":108,"biomarkers":110},[109],"Kidney Transplantation",[],{"nct_id":4,"found":112,"summary":113,"prompt_version":123},true,{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This interventional study compares letermovir to a historical control group that received valganciclovir. It aims to enroll 300 participants.","completed","Letermovir vs Valganciclovir for CMV Prevention in Kidney Transplant","This study is looking at whether letermovir can prevent cytomegalovirus (CMV) infection in people who have received a kidney transplant and are already CMV positive (meaning they've been exposed to CMV before). Researchers will compare patients who received letermovir with a group of past patients who received valganciclovir. Both medications are given for 90 days after the transplant. The main goal is to see if letermovir prevents CMV infection as well as valganciclovir during the first 12 months after a kidney transplant. They will also look at whether letermovir is easier to tolerate. This study plans to enroll 300 participants, but its current status is unclear.","The primary outcome of CMV infection will be measured at 12 months post kidney transplant.",106,"Participants will receive either letermovir or valganciclovir for 90 days after their kidney transplant. Males must use contraception for 290 days, and females of child-bearing potential must follow contraception guidance for 290 days.","Not stated in the trial record.",[25],"v2"]