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Comparison of Two Immunosuppressive Regimens in Kidney Transplant Recipients With Deceased Donors With the Aim of Preventing the Development of Fibrosis / Atrophy of Reducing the Incidence of Cytomegalovirus Infection

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Federal University of São Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01353053
First Posted: May 12, 2011
Last Update Posted: May 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  Purpose
The aim of this the study is to the assess whether the graft and patient survival, rejection rates and renal graft function after the first year will not differ between both study arms. The investigators will also the evaluate the reduction in the incidence of cytomegalovirus the and improvement of renal function of the everolimus after 1 year.

Condition
Disorder of Transplanted Kidney Cytomegalovirus Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Two Immunosuppressive Regimens in Kidney Transplant Recipients With Deceased Donors With the Aim of Preventing the Development of Fibrosis / Atrophy of Reducing the Incidence of Cytomegalovirus Infection

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Estimated Enrollment: 82
Study Start Date: July 2010
Groups/Cohorts
Tacrolimus, Everolimus
Immunosuppression is the same for all patients in the study until the period between the 3rd and 5th weeks, when patients will be randomized to initial regimen and remain or be converted to everolimus tacrolimus.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A randomized study of 82 patients transplanted in first transplant recipients of deceased donor and in line for kidney transplantation.
Criteria

Inclusion Criteria:

  • Patients with BMI below 30,
  • first transplants with PRA < 30,
  • no contraindication for induction Thymoglobuline,
  • age 18 years or younger than 70 years.

Exclusion Criteria:

  • patients with a BMI above 30
  • retransplantation
  • patients hypersensitized with PRA > 30
  • compared with Thymoglobulina indication for induction
  • age under 18 or over 70 years
  Contacts and Locations
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): NCT01353053


Locations
Brazil
Hospital Israelita Albert Einstein Recruiting
Sao Paulo, SP, Brazil
Contact: Lucio Requião Moura    55-11    lrequiao@nefro.epm.br   
Principal Investigator: Alvaro Pacheco-Silva, Doctor         
Sponsors and Collaborators
Federal University of São Paulo
  More Information

Responsible Party: Alvaro Pacheco e Silva Filho, Federal University of Sao Paolo
ClinicalTrials.gov Identifier: NCT01353053     History of Changes
Other Study ID Numbers: 056410
First Submitted: May 11, 2011
First Posted: May 12, 2011
Last Update Posted: May 12, 2011
Last Verified: May 2010

Keywords provided by Federal University of São Paulo:
Immunosuppression
Cytomegalovirus
Renal Transplant
Atrophy/interstitial
Conversion of tacrolimus everolimus

Additional relevant MeSH terms:
Infection
Communicable Diseases
Atrophy
Cytomegalovirus Infections
Pathological Conditions, Anatomical
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Everolimus
Sirolimus
Tacrolimus
Immunosuppressive Agents
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action