Overview

Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence

Status:
Unknown status
Trial end date:
2020-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital do Rim e Hipertensão
Treatments:
Azathioprine
Everolimus
Mycophenolate mofetil
Mycophenolic Acid
Prednisone
Sirolimus
Tacrolimus
Criteria
Inclusion Criteria:

- Adult kidney transplant recipients > 18 y.o.

- Kidney Transplant recipients, after the first episode of cytomegalovirus infection,
using the current immunosuppressive regimen: azathioprine or mycophenolate, tacrolimus
and prednisone.

Exclusion Criteria:

- Re-transplant;

- Patients with any panel reactive antibody (PRA) equal to or above 50%, class I or
class II;

- Acute rejection episode in the last 30 days, or episode > 2A in the Banff criteria;

- GFR (MDRD) < 40 ml/min;

- Proteinuria > 0,5 g/l;

- Hemoglobin < 10 g/l and/or leucocytes < 4000 cels/mm3 and/or platelets < 150.000
cels/mm3;

- Triglycerides > 500 mg/dl with or without use of fibrate;

- Cholesterol total > 300 mg/dl with or without use of statin;

- Hepatic abnormalities;

- Significant periphery edema;

- Pulmonary abnormalities or breast x-ray abnormalities;

- Hyper sensibility to sirolimus formula;