drugset / Trial / NCT02671318

Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence

NCT02671318

Phase 4 Unknown 250 enrolled Hospital do Rim e Hipertensão
RandomizedParallel-groupOpen-labelPrevention

Summary

Cytomegalovirus is the most important opportunistic infection after kidney transplant, with increased in mortality, morbidity and higher costs of transplantation. Despite the favorable efficacy (lower acute rejection) results of the most worldwide used regime, tacrolimus, mycophenolate and prednisone, or the investigators local common regimen, tacrolimus, azathioprine and prednisone, this combinations are associated with higher incidence of cytomegalovirus infection, disease and recurrence. Namely, sirolimus use is associated with decreased risk of cytomegalovirus infection/disease, and there is not a prospective cohort to evaluate the conversion to sirolimus efficacy to decrease the cytomegalovirus infection recurrence. Given this, the investigators propose a study of their own initiative that attends local needs: evaluate the conversion to sirolimus efficacy in decrease the cytomegalovirus recurrence after kidney transplant.

Timeline

Start
2015-09
Primary completion
2019-12
Completion
2020-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Azathioprine Small molecule
Comparator Mycophenolate Sodium Unknown
Comparator Sirolimus Small molecule
Comparator Prednisone Other / unclassified
Comparator Tacrolimus Small molecule