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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

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ClinicalTrials.gov Identifier: NCT01353053
Recruitment Status : Unknown
Verified May 2010 by Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : May 12, 2011
Last Update Posted : May 12, 2011
Sponsor:
Information provided by:
Federal University of São Paulo

May 11, 2011
May 12, 2011
May 12, 2011
July 2010
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No Changes Posted
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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
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 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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
A randomized study of 82 patients transplanted in first transplant recipients of deceased donor and in line for kidney transplantation.
  • Disorder of Transplanted Kidney
  • Cytomegalovirus Infections
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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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
82
Same as current
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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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01353053
056410
No
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Alvaro Pacheco e Silva Filho, Federal University of Sao Paolo
Federal University of São Paulo
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Federal University of São Paulo
May 2010