Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence

Cytomegalovirus Infections Clinical Trial

— StopCMV  

Official title:

Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence in Kidney Transplant Recipients (StopCMV: S=Sirolimus CMV= Cytomegalovirus)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02671318
• Other study ID #: 43102815.0.0000.5505
• Status: Recruiting
• Phase: Phase 4
• First received: January 26, 2016
• Last updated: August 15, 2016
• Start date: September 2015
• Est. completion date: August 2020

Study information

• Verified date: August 2016
• Source: Hospital do Rim e Hipertensão
• Contact: Geovana Basso, MD
• Phone: +55 11 50878000
• Email: geovana_basso[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Cytomegalovirus Infections
• Infection
• Recurrence

Intervention

Drug:
• Drug conversion to sirolimus
Drug conversion to sirolimus: mycophenolate or azathioprine conversion to sirolimus, in a regimen with tacrolimus and prednisone.
• Maintenance of the current regimen
Maintenance of the current regimen: mycophenolate or azathioprine maintenance, in a regimen with tacrolimus and prednisone.

Locations

Country	Name	City	State
Brazil	Hospital do Rim	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Rim e Hipertensão

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytomegalovirus infection/disease recurrence	Cytomegalovirus infection/disease recurrence	One year	Yes