Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After Kidney Transplantation in Adults

Phase 4

• Conditions: Kidney Transplant; Immunosuppression
• Interventions: Drug: Everolimus; Drug: calcineurin inhibitor

• Registration Number: NCT01455649
• Lead Sponsor: Deise de Boni Monteiro de Carvalho

Brief Summary

The purpose of this study is to demonstrate the efficacy and safety in the use of everolimus, with its onset after 3 months of treatment with calcineurin inhibitor.

Detailed Description

The patient who met the inclusion and exclusion criteria will be included in the study and randomized into two groups in the third month post transplant, they will be in use of tacrolimus, corticosteroids and Mycophenolate sodium. The group 1 will undergo a conversion from calcineurin inhibitor to Everolimus within 1 day (overnight), group 2 will be maintained with the initial immunosuppression. We will start Everolimus at 1 mg 2x/day and three days after the beginning we will adjust the dose by the serum levels, which will be kept in 6 to 10ng/dL. The doses of corticosteroids and Mycophenolate sodium will be retained. There will be performed renal biopsies at randomization and after 12 months. The glomerular filtration rate will be calculated monthly using the MDRD.

Study Timeline

• Status Verified: 2011-10
• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-10-19
• Last Update Submitted: 2011-10-19
• Study First Posted: 2011-10-20
• Last Update Posted: 2011-10-20
• Study Start: 2011-11
• Primary Completion: 2013-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients aged from 18 to 65 years old
• First transplantation recipients
• PRA < 30%
• Living or cadaveric donor
• Stable renal function
• Patients not pregnant or breastfeeding , where pregnancy is defined as the woman status from conception to gestation conclusion, through a positive beta hCG test (>5mUI/mL)
• Provided written informed consent form

Exclusion Criteria

• Cadaveric donor with expanded criterion
• Multiple organs transplantation
• Kidney cold ischemia time > 24 hours
• Severe rejection episode - Banf >IIA
• Glomerular filtration rate < 35mL/min
• Presence of hard to treat dyslipidemia - severe hypercholesterolemia (>350mg/dL) or hypertriglyceridemia (>500mg/dL)
• Proteinuria > 800mg/24h
• Patients with history of malignancy of any organic system, treated or not, within 5 years, with or without evidence of local recurrence or metastases, other than localized basal cell carcinoma
• Female with childbearing potential without using a reliable contraceptive method.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Everolimus	Everolimus	-
calcineurin inhibitor	calcineurin inhibitor	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Creatinine Clearance at 24 months	baseline and two years	The primary objective is to demonstrate the effectiveness and non-inferiority of treatment with everolimus, by assessing renal function, in comparison with the use of calcineurin inhibitor.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	baseline and two years	The secondary objective is to demonstrate the safety by comparing rejection episodes, graft loss, infection, cancer and death in the control group

Trial Locations

Locations (1)

Hospital federal de Bonsucesso; 🇧🇷 Rio de Janeiro, Brazil