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

NCT01353053 | Unknown

• 1 other identifier: 056410
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Disorder of Transplanted Kidney; Cytomegalovirus Infections

Keywords

Immunosuppression; Cytomegalovirus; Renal Transplant; Atrophy/interstitial; Conversion of tacrolimus everolimus

Study Arms (1)

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 Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with BMI below 30,
• first transplants with PRA \< 30,
• no contraindication for induction Thymoglobuline,
• age 18 years or younger than 70 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections; Atrophy

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 12, 2011
• Study Start: July 1, 2010
• Last Updated: May 12, 2011

Record last verified: 2010-05

Locations

BR (1)