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:

MedlinePlus related topics: Cytomegalovirus Infections Kidney Transplantation

Drug Information available for: Sirolimus Tacrolimus Everolimus Temsirolimus

U.S. FDA Resources

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

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
Fibrosis
Atrophy
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Pathologic Processes

Pathological Conditions, Anatomical
Immunosuppressive Agents
Everolimus
Tacrolimus
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013

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