NCT01608412

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

An Open-label Randomized Controlled Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus 3 Months After Kidney Transplantation.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Tacrolimus	TACROLIMUS (C0 = 5-10 ng/mL) + MPS 1440 mg + Pred
DRUG	Everolimus	Everolimus (C0 = 6-10 ng/mL) + MPS 1440 mg + Pred

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-05-31
• Last updated: 2012-05-31

Locations

1 site across 1 country: Brazil