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Certican (Everolimus) for Recipients of Kidney From HLA-identical Living Donors

NCT01653041 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2016-08-16

No results posted yet for this study

Summary

Recipients from living donors kidneys HLA-identical were lower risk for acute rejection, graft loss or death. There is no clear definition of what is ideal immunosuppressive regimen for this population.

Everolimus (EVR) was associated with lower incidence of viral infections and also the lowest incidence of neoplasms. Furthermore, immunosuppressive regimens based everolimus allow the reduction or elimination of calcineurin inhibitors reducing cardiovascular risks associated with chronic use of these agents. Moreover, the use of EVR is associated with increased incidence of proteinuria, which associated mechanism has not been fully elucidated. Knowing that proteinuria may be the first indication of recurrence of the underlying renal disease, detailed information about the patient's medical history and histological analysis of the graft may contribute with additional knowledge in this area.

The aim of this prospective, open, single arm study that will be performed only in the Hospital do Rim e Hipertensão, is investigating the outcomes of kidney transplantation in recipients of HLA identical living donor, receiving an everolimus-based immunosuppressive regimen. This will include 100 recipients of first or second kidney transplant from a living donor HLA identical to the Kidney and Hypertension Hospital, which will be followed by a period of 12 months.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Everolimus

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Hospital do Rim e Hipertensão

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-08-31
Completion
2015-04-30

Countries

  • Brazil

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01653041 on ClinicalTrials.gov