[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608600":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":50,"collaborators":26,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":26,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":26,"enrollmentInfo":63,"targetDuration":26,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":26,"overallStatus":72,"whyStopped":26,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Hospital Universitario La Paz","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"mTOR inhibitors","EXPERIMENTAL","Preemptive therapy will be administered as a preventive strategy, consisting of initiating antiviral treatment with valganciclovir (900 mg every 12 hours, adjusted according to renal function as per the technical data sheet) when CMV viral replication in blood exceeds 1,000 copies\u002Fml. Treatment will be discontinued once viral load becomes undetectable in two consecutive tests",[13],"Combination Product: steroids, tacrolimus and mTOR inhibitors",{"label":15,"type":16,"description":17,"interventionNames":18},"Universal prophylaxis","ACTIVE_COMPARATOR","As a preventive strategy against CMV, the patient will receive universal prophylaxis, and for maintenance immunosuppressive treatment, steroids, tacrolimus, and mycophenolic acid will be administered.",[19],"Combination Product: steroids, tacrolimus and mycophenolic acid.",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","steroids, tacrolimus and mTOR inhibitors","Patients receive immunosuppressive induction treatment with thymoglobulin (at least 1 dose and maximum of 5 doses) and immunosuppressive maintenance treatment with tacrolimus + mTOR inhibitors. Preemptive therapy will be administered as a preventive strategy, consisting of initiating antiviral treatment with valganciclovir (900 mg every 12 hours, adjusted according to renal function as per the technical data sheet) when CMV viral replication in blood exceeds 1,000 copies\u002Fml. Treatment will be discontinued once viral load becomes undetectable in two consecutive tests.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"steroids, tacrolimus and mycophenolic acid.","Patients will receive immunosuppressive induction treatment with thymoglobulin (at least 1 dose and a maximum of 5 doses) and tacrolimus + mycophenolic acid following the guidelines of the technical file and the centre's usual protocols.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"María O. López Oliva, Dra","CONTACT","+34 91 727 70 00","mlopezo@salud.madrid.org",[38],{"facility":39,"status":26,"city":40,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":26},"Hospital Universitario La Paz, Pº de la Castellana, 261 (Servicio de Nefrologia)","Madrid","28046","Spain","ES",{"type":45,"coordinates":46},"Point",[47,48],-3.70256,40.4165,{"lat":48,"lon":47},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","María Ovidia López Oliva","Dra.","100608600","phase-4-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-100608600",false,"NCT07203664","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.","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. Phase 4 Clinical Trial. TIMTOR STUDY.","Inclusion Criteria:\n\n* Age 18 years or more.\n* Positive pre-transplant Ig G CMV serology.\n* Receive immunosuppressive induction treatment with thymoglobulin (between 1 and 5 doses).\n* Agree to participate in the study by signing the informed consent form.\n\nExclusion Criteria:\n\n* Patients with negative pre-transplant Ig G CMV serology.\n* HIV-infected patients.\n* Patients receiving induction therapy with basiliximab.\n* Patients who cannot comply with the follow-up protocol.\n* Patients who cannot receive iMTOR as initial maintenance immunosuppressive therapy, such as patients with chronic kidney disease secondary to hepatorenal polycystic kidney disease and patients who are expected to undergo complex vascular surgery.\n* Patients who for any reason should not be included in the study according to the evaluation of the research team.","ALL","18 Years",{"count":64,"type":65},30,"ESTIMATED","INTERVENTIONAL",[68],"PHASE4","The overall objective of this project is to optimise preventive treatment of CMV infection\u002Fdisease in renal transplant recipients at increased risk of CMV post-transplantation. The specific objectives are: (1) To compare the incidence of CMV infection\u002Fdisease at 6 months post-transplant in Ig G CMV positive (R+CMV) recipients receiving induction treatment with thymoglobulin and one of the two maintenance immunosuppressive treatment regimens used in routine clinical practice : tacrolimus and MTOR inhibitors (group 1) or tacrolimus and mycophenolic acid (group 2); (2) To monitor CMV-specific cellular immunity before transplantation, at 15, 30 and 90 days post-transplantation. For this purpose, an exploratory phase 4 clinical trial has been designed in which will select 30 R+CMV patients receiving renal transplantation with induction treatment with thymoglobulin. After signing informed consent, patients will be randomised to receive one of the two immunosuppression regimens indicated above. The patients in group 1 will receive early therapy as a CMV prevention strategy and patients in group 2 will receive universal prophylaxis for 3 months. Follow-up visits to will be conducted according to the usual protocol and clinical and virological variables will be collected. In addition, blood samples will be collected for the assessment of CMV-specific cellular immunity before and after transplantation. The primary endpoint is the presence of CMV infection\u002Fdisease post-renal transplantation at 6 months. Secondary variables include renal function, acute rejection, patient and graft survival and the occurrence of surgical or haematological complications.",[71],"Evaluate the Effectiveness of CMV Prevention Strategies in Kidney Transplant Recipients","NOT_YET_RECRUITING","2025-10-01",{"date":75,"type":76},"2025-10-02","ACTUAL",{"date":78,"type":65},"2025-10-30",{"date":80,"type":65},"2026-12-31",{"name":5,"class":6},1]