Status:
NOT_YET_RECRUITING
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.
Lead Sponsor:
Hospital Universitario La Paz
Conditions:
Evaluate the Effectiveness of CMV Prevention Strategies in Kidney Transplant Recipients
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The overall objective of this project is to optimise preventive treatment of CMV infection/disease in renal transplant recipients at increased risk of CMV post-transplantation. The specific objectives...
Detailed Description
HYPOTHESIS The use of immunosuppressive maintenance therapy including mTOR inhibitors versus the use of mycophenolic acid in kidney transplant patients with an increased risk of post-transplant CMV di...
Eligibility Criteria
Inclusion
- Age 18 years or more.
- Positive pre-transplant Ig G CMV serology.
- Receive immunosuppressive induction treatment with thymoglobulin (between 1 and 5 doses).
- Agree to participate in the study by signing the informed consent form.
Exclusion
- Patients with negative pre-transplant Ig G CMV serology.
- HIV-infected patients.
- Patients receiving induction therapy with basiliximab.
- Patients who cannot comply with the follow-up protocol.
- 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.
- Patients who for any reason should not be included in the study according to the evaluation of the research team.
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07203664
Start Date
October 30 2025
End Date
December 31 2026
Last Update
October 2 2025
Active Locations (1)
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1
Hospital Universitario La Paz, Pº de la Castellana, 261 (Servicio de Nefrologia)
Madrid, Madrid, Spain, 28046