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.

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 30, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Evaluate the Effectiveness of CMV Prevention Strategies in Kidney Transplant Recipients
Interventions
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/ml. Treatment will be discontinued once viral load becomes undetectable in two consecutive tests.

COMBINATION_PRODUCT

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.

Trial Locations (1)

28046

Hospital Universitario La Paz, Pº de la Castellana, 261 (Servicio de Nefrologia), Madrid

All Listed Sponsors
lead

Hospital Universitario La Paz

OTHER