Clinical trial NCT02671318: Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence
Official title: Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence in Kidney Transplant Recipients (StopCMV: S=Sirolimus CMV= Cytomegalovirus)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cytomegalovirus Infections
Keywords: cytomegalovirus
sirolimus
cytomegalovirus recurrence
kidney transplant
conversion
Lead sponsor: Hospital do Rim e Hipertensão
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This protocol is a prospective, randomized, single center, designed to evaluate incidence of cytomegalovirus recurrence infection/disease in two immunosuppressive regimens, after the first episode of cytomegalovirus: (1) conversion of azathioprine or mycophenolate to sirolimus, in a regimen wih low doses tacrolimus and prednisone; ( 2) Maintenance of the current regimen during the first episode of cytomegalovirus infection ( azathioprine or mycophenolate, in combination to tacrolimus or prednisone). Our hypothesis is that conversion from azathioprine or sodium mycophenolate to sirolimus, with low doses of tacrolimus, and prednisone results in lower recurrence of cytomegalovirus infection/disease in kidney transplant recipients.

Eligibility 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;

Primary outcomes:
measure: Cytomegalovirus infection/disease recurrence
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital do Rim
Study officials:
affiliation: Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
name: Geovana Basso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
name: Helio Tedesco Silva Junior, PhD
role: STUDY_CHAIR
affiliation: Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
name: Claudia Rosso felipe, PhD
role: STUDY_CHAIR
affiliation: Brigham and Women's Hospital, US.
name: Leonardo V. Riella, PhD
role: STUDY_CHAIR
affiliation: Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
name: Jose O. Medina Pestana, PhD
role: STUDY_CHAIR
References: