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.
Drug: calcineurin inhibitor
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01455649
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
Provided written informed consent form
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.
All locations for NCT01455649
Hospital federal de Bonsucesso
Rio de Janeiro, Brazil, 21041-030
View full eligibility
Tris trial is registered with FDA with number: NCT01455649. The sponsor of the trial is Deise de Boni Monteiro de Carvalho and it is looking for 30 volunteers for the current phase.
Official trial title: A Prospective, Open-label, Controlled, Randomized Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After 90 to 150 Days After Kidney Transplantation in Adults, Maintaining Corticosteroid and Mycophenolate Sodium Compared to Patients Who Will Maintain the Use of Calcineurin Inhibitor
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