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NCT01353053 Clinical Trial

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

Cytomegalovirus Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01353053
Other study ID # 056410
Secondary ID
Status Recruiting
Phase N/A
First received May 11, 2011
Last updated May 11, 2011
Start date July 2010

Study information
Verified date May 2010
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Agency for Sanitary Surveillance
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 82
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil Hospital Israelita Albert Einstein Sao Paulo SP

Sponsors (1)
Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

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