drugset / Trial / NCT04936971

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

NCT04936971

Phase 4 Withdrawn Edoardo Melilli
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2021-09
Primary completion
2021-09
Completion
2021-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Everolimus Small molecule
Comparator Mycophenolate Mofetil Small molecule 500 mg