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Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients

NCT02683291 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-02-17

No results posted yet for this study

Summary

There is no consensus on the best immunosuppressive regimen in elderly people. The aim of this study will be to evaluate the efficacy of sirolimus associated with tacrolimus in elderly kidney transplant recipients. The investigators will conduct a single-center prospective randomized study comparing the combination of tacrolimus with sirolimus at reduced dose rate (tacrolimus + sirolimus group) against tacrolimus with mycophenolate (tacrolimus + mycophenolate group). The investigators will include all kidney transplant patients over 60 years of age. The investigators will evaluate estimated glomerular filtration rate and incidence of cytomegalovirus in 12 month follow-up.

Conditions

  • Disorder Related to Renal Transplantation
  • Cytomegalovirus Infections

Interventions

DRUG

sirolimus

DRUG

tacrolimus

DRUG

mycophenolate

DRUG

Prednisone

Prednisone 30mg/day

DRUG

Basiliximab

Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %

DRUG

Thymoglobulin

Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %

Sponsors & Collaborators

  • Associação Médico Espírita de Botucatu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-01-31
Completion
2016-01-31

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Drugs

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 NCT02683291 on ClinicalTrials.gov