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Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response

NCT04936971 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-02-28

No results posted yet for this study

Summary

Kidney transplant patients under an immunosuppressive treatment based on anti-calcineurin and mycophenolate-mofetil and induction therapy with rATG who suffer from early systemic viral replication by the CMV virus could benefit from the introduction of an i-mTor drug. (everolimus) to replace mycophenolate mofetil. This conversion would be effective in slowing down and controlling viral expansion without the need to initiate any prophylactic anti-viral therapy thanks to the activation of the CMV-specific cellular effector response or to an antiviral effect of i-Mtor itself.

Conditions

  • Kidney Transplantation
  • Cytomegalovirus Infections

Interventions

DRUG

Switch from Mycophenolate Mofetil to Everolimus manteinance treatment in Active Comparator Arm

Switch from Mycophenolate Mofetil in Active comparator Arm if assymptomatic Cytomegalovirus viremia \>1000-\<5000 copies/mL observed

OTHER

no intervention

Manteinance of assigned Arm treatment even if assymptomatic Cytomegalovirus viremia \>1000-\<5000 copies/mL observed

Sponsors & Collaborators

  • Edoardo Melilli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04936971 on ClinicalTrials.gov