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Trial record 12 of 296 for:    "Cytomegalic inclusion disease"

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

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ClinicalTrials.gov Identifier: NCT02671318
Recruitment Status : Recruiting
First Posted : February 2, 2016
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
Geovana Basso, Hospital do Rim e Hipertensão

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.


Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections Drug: Drug conversion to sirolimus Drug: Maintenance of the current regimen Phase 4

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  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence in Kidney Transplant Recipients (StopCMV: S=Sirolimus CMV= Cytomegalovirus)
Study Start Date : September 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : August 2020


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 Name: 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




Primary Outcome Measures :
  1. Cytomegalovirus infection/disease recurrence [ Time Frame: One year ]
    Cytomegalovirus infection/disease recurrence



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671318


Contacts
Contact: Geovana Basso, MD +55 11 50878000 geovana_basso@hotmail.com

Locations
Brazil
Hospital do Rim Recruiting
São Paulo, Brazil, 04037-003
Contact: Geovana Basso, MD    +55 11 5087-8000    geovana_basso@hotmail.com   
Sponsors and Collaborators
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

Responsible Party: Geovana Basso, MD, Hospital do Rim e Hipertensão
ClinicalTrials.gov Identifier: NCT02671318     History of Changes
Other Study ID Numbers: 43102815.0.0000.5505
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Geovana Basso, Hospital do Rim e Hipertensão:
cytomegalovirus
sirolimus
cytomegalovirus recurrence
kidney transplant
conversion

Additional relevant MeSH terms:
Cytomegalovirus Infections
Infection
Communicable Diseases
Recurrence
Disease Attributes
Pathologic Processes
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Prednisone
Sirolimus
Everolimus
Mycophenolic Acid
Azathioprine
Tacrolimus
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic