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Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence

NCT02671318 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2016-08-17

No results posted yet for this study

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.

Conditions

  • Cytomegalovirus Infections

Interventions

DRUG

Drug conversion to sirolimus

Drug conversion to sirolimus: mycophenolate or azathioprine conversion to sirolimus, in a regimen with tacrolimus and prednisone.

DRUG

Maintenance of the current regimen

Maintenance of the current regimen: mycophenolate or azathioprine maintenance, in a regimen with tacrolimus and prednisone.

Sponsors & Collaborators

  • Hospital do Rim e Hipertensão

    lead OTHER

Principal Investigators

  • Geovana Basso, MD · Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

  • Helio Tedesco Silva Junior, PhD · Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

  • Claudia Rosso felipe, PhD · Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

  • Leonardo V. Riella, PhD · Brigham and Women's Hospital, US.

  • Jose O. Medina Pestana, PhD · Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-12-31
Completion
2020-08-31

Countries

  • Brazil

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 NCT02671318 on ClinicalTrials.gov