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Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence (StopCMV)

Primary Purpose

Cytomegalovirus Infections

Status

Unknown status

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Drug conversion to sirolimus

Maintenance of the current regimen

About this trial

This is an interventional prevention trial for Cytomegalovirus Infections focused on measuring cytomegalovirus, sirolimus, cytomegalovirus recurrence, kidney transplant, conversion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Hospital do RimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Drug conversion to sirolimus

Maintenance of the current regimen

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cytomegalovirus infection/disease recurrence

Secondary Outcome Measures

Full Information

NCT ID

NCT02671318

First Posted

January 26, 2016

Last Updated

August 15, 2016

Sponsor

Hospital do Rim e Hipertensão

1. Study Identification

Unique Protocol Identification Number

NCT02671318

Brief Title

Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence

Acronym

StopCMV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital do Rim e Hipertensão

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cytomegalovirus Infections

Keywords

cytomegalovirus, sirolimus, cytomegalovirus recurrence, kidney transplant, conversion

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Drug conversion to sirolimus

Arm Type

Active Comparator

Arm Description

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

Arm Title

Maintenance of the current regimen

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Drug conversion to sirolimus

Other Intervention Name(s)

Rapamune

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Maintenance of the current regimen

Other Intervention Name(s)

Myfortic, Immuran

Intervention Description

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

Primary Outcome Measure Information:

Title

Cytomegalovirus infection/disease recurrence

Description

Cytomegalovirus infection/disease recurrence

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Geovana Basso, MD

Phone

+55 11 50878000

geovana_basso@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Geovana Basso, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Helio Tedesco Silva Junior, PhD

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Claudia Rosso felipe, PhD

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Leonardo V. Riella, PhD

Organizational Affiliation

Brigham and Women's Hospital, US.

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jose O. Medina Pestana, PhD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital do Rim

City

São Paulo

ZIP/Postal Code

04037-003

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Geovana Basso, MD

Phone

+55 11 5087-8000

geovana_basso@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence

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