Status:
UNKNOWN
Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After Kidney Transplantation in Adults
Lead Sponsor:
Deise de Boni Monteiro de Carvalho
Conditions:
Kidney Transplant
Immunosuppression
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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, corticoster...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01455649
Start Date
November 1 2011
End Date
November 1 2013
Last Update
October 20 2011
Active Locations (1)
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1
Hospital federal de Bonsucesso
Rio de Janeiro, Rio de Janeiro, Brazil, 21041-030