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

• Status: Unknown status
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deise de Boni Monteiro de Carvalho
• Treatments: Calcineurin Inhibitors; Cyclosporine; Cyclosporins; Everolimus; Sirolimus; Tacrolimus

Criteria

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.