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A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus

NCT01608412 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-05-31

No results posted yet for this study

Summary

The study hypotheses to be tested in this study are:

* Conversion to everolimus at 3 months post-transplantation is safe and effective;
* Accurate noninvasive molecular diagnostic tests can replace biopsy at 3 months pre-conversion (for the diagnosis of subclinical cellular and/or humoral rejection, tissue fibrosis and calcineurin inhibitor-induced nephrotoxicity) in kidney transplant recipients;
* Follow-up biopsy at 12 months post-conversion (for the diagnosis of tissue fibrosis) can be replaced with accurate noninvasive molecular diagnostic tests in kidney transplant recipients.

Conditions

  • Kidney Transplant Recipients

Interventions

DRUG

Tacrolimus

TACROLIMUS (C0 = 5-10 ng/mL) + MPS 1440 mg + Pred

DRUG

Everolimus

Everolimus (C0 = 6-10 ng/mL) + MPS 1440 mg + Pred

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Luiz Felipe S. Gonçalves, MD · HCPA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

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 NCT01608412 on ClinicalTrials.gov