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Use of tacrolimus and MTOR inhibitors with anticipatory therapy vs. tacrolimus and mycophenolic acid with universal prophylaxis in renal recipients at high risk of post-transplant cytomegalovirus. Phase IV clinical trial (TIMTOR STUDY).

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520854-12-00
Acronym
TIMTOR
Enrollment
30
Registered
2025-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced chronic renal insufficiency

Brief summary

Primary endpoint: Presence of CMV infection or disease after renal transplantation. This variable will be evaluated at 6 months post-transplantation.

Detailed description

Recipient demographic variables: gender and age, Recipient variables related to chronic kidney disease (CKD): etiology of CKD, renal replacement therapy (RRT) prior to transplantation, time on RRT in months., Donor variables: demographics (age and sex), cause of death, donor type (living, cadaveric and cadaveric donor type), Ig G CMV serology., Peri-transplant variables, CMV-related variables

Interventions

DRUGValganciclovir Aurovitas 450 mg comprimidos recubiertos con película EFG
DRUGUrbason 40 mg polvo y disolvente para solución inyectable
DRUGprednisona cinfa 5 mg comprimidos EFG
DRUGMyfortic 180 mg comprimidos gastrorresistentes.

Sponsors

Hospital Universitario La Paz
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Primary endpoint: Presence of CMV infection or disease after renal transplantation. This variable will be evaluated at 6 months post-transplantation.

Secondary

MeasureTime frame
Recipient demographic variables: gender and age, Recipient variables related to chronic kidney disease (CKD): etiology of CKD, renal replacement therapy (RRT) prior to transplantation, time on RRT in months., Donor variables: demographics (age and sex), cause of death, donor type (living, cadaveric and cadaveric donor type), Ig G CMV serology., Peri-transplant variables, CMV-related variables

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026