Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence

NCT ID: NCT02671318

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2020-08-31

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.

Conditions

Cytomegalovirus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Drug conversion to sirolimus

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

Group Type: ACTIVE_COMPARATOR

Drug conversion to sirolimus

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Maintenance of the current regimen

Intervention Type: DRUG

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

Interventions

Drug conversion to sirolimus

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

Intervention Type: DRUG

Maintenance of the current regimen

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

Intervention Type: DRUG

Other Intervention Names

Rapamune; Myfortic; Immuran

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital do Rim e Hipertensão

OTHER

Sponsor Role: lead

Responsible Party

Geovana Basso

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geovana Basso, MD

Role: PRINCIPAL_INVESTIGATOR

Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

Helio Tedesco Silva Junior, PhD

Role: STUDY_CHAIR

Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

Claudia Rosso felipe, PhD

Role: STUDY_CHAIR

Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

Leonardo V. Riella, PhD

Role: STUDY_CHAIR

Brigham and Women's Hospital, US.

Jose O. Medina Pestana, PhD

Role: STUDY_CHAIR

Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

Locations

Hospital do Rim

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Geovana Basso, MD

Role: CONTACT

geovana_basso@hotmail.com

+55 11 50878000

Facility Contacts

Geovana Basso, MD

Role: primary

geovana_basso@hotmail.com

+55 11 5087-8000

References

Viana LA, Cristelli MP, Basso G, Santos DW, Dantas MTC, Dreige YC, Requiao Moura LR, Nakamura MR, Medina-Pestana J, Tedesco-Silva H. Conversion to mTOR Inhibitor to Reduce the Incidence of Cytomegalovirus Recurrence in Kidney Transplant Recipients Receiving Preemptive Treatment: A Prospective, Randomized Trial. Transplantation. 2023 Aug 1;107(8):1835-1845. doi: 10.1097/TP.0000000000004559. Epub 2023 Jul 20.

Reference Type: DERIVED

PMID: 37046380 (View on PubMed)

Other Identifiers

43102815.0.0000.5505

Identifier Type: -

Identifier Source: org_study_id