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

NCT ID: NCT01353053

Last Updated: 2011-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Disorder of Transplanted Kidney Cytomegalovirus Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Federal University of Sao Paolo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lucio Requião Moura

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

056410

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.