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 because the information has not been verified recently.
Verified May 2010 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01353053
First received: May 11, 2011
Last updated: NA
Last verified: May 2010
History: No changes posted
  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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alvaro Pacheco e Silva Filho, Federal University of Sao Paolo
ClinicalTrials.gov Identifier: NCT01353053     History of Changes
Other Study ID Numbers: 056410
Study First Received: May 11, 2011
Last Updated: May 11, 2011
Health Authority: Brazil: National Agency for Sanitary Surveillance

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

Additional relevant MeSH terms:
Cytomegalovirus Infections
Infection
Communicable Diseases
Atrophy
Pathological Conditions, Anatomical
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Everolimus
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014