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

Deise de Boni Monteiro de Carvalho

Status and phase

Unknown

Phase 4

Conditions

Kidney Transplant

Immunosuppression

Treatments

Drug: calcineurin inhibitor

Drug: Everolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT01455649

CRAD001ABR17T

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.