Immunosuppression, Kidney Transplant
Conditions
Keywords
Kidney, Transplant, Immunosuppression, Everolimus, Graft function
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.
Interventions
DRUGEverolimus
Group will switch calcineurin inhibitor to everolimus within 1 day (overnight).
Group will maintain their initial immunosuppression therapy with calcineurin inhibitor
Sponsors
Deise de Boni Monteiro de Carvalho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Contacts
Primary ContactDeise BM Carvalho, MD
Outcome results
None listed