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

August 15, 2016 updated by: Geovana Basso, Hospital do Rim e Hipertensão

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • São Paulo, Brazil, 04037-003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Drug conversion to sirolimus
Drug conversion to sirolimus: mycophenolate or azathioprine conversion to sirolimus, in a regimen with tacrolimus and prednisone.
Drug: Drug conversion to sirolimus
Drug conversion to sirolimus: mycophenolate or azathioprine conversion to sirolimus, in a regimen with tacrolimus and prednisone.
Other Names:
  • Rapamune
Active Comparator: Maintenance of the current regimen
Maintenance of the current regimen: mycophenolate or azathioprine maintenance, in a regimen with tacrolimus and prednisone.
Drug: Maintenance of the current regimen
Maintenance of the current regimen: mycophenolate or azathioprine maintenance, in a regimen with tacrolimus and prednisone.
Other Names:
  • Myfortic
  • Immuran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytomegalovirus infection/disease recurrence
Time Frame: One year
Cytomegalovirus infection/disease recurrence
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital do Rim e Hipertensão

Investigators

  • Principal Investigator: Geovana Basso, MD, Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
  • Study Chair: Helio Tedesco Silva Junior, PhD, Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
  • Study Chair: Claudia Rosso felipe, PhD, Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
  • Study Chair: Leonardo V. Riella, PhD, Brigham and Women's Hospital, US.
  • Study Chair: Jose O. Medina Pestana, PhD, Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Estimate)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 15, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43102815.0.0000.5505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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