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

May 11, 2011 updated by: Federal University of São Paulo
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

82

Contacts and Locations

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

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil
        • Recruiting
        • Hospital Israelita Albert Einstein
        • Contact:
        • Principal Investigator:
          • Alvaro Pacheco-Silva, Doctor

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

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

Cohorts and Interventions

Group / Cohort
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.

Collaborators and Investigators

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

Sponsor

Federal University of São Paulo

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

July 1, 2010

Study Registration Dates

First Submitted

May 11, 2011

First Submitted That Met QC Criteria

May 11, 2011

First Posted (Estimate)

May 12, 2011

Study Record Updates

Last Update Posted (Estimate)

May 12, 2011

Last Update Submitted That Met QC Criteria

May 11, 2011

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 056410

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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