Clinical trial NCT01455649: Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After Kidney Transplantation in Adults
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Transplant
Immunosuppression
Keywords: Kidney
Transplant
Immunosuppression
Everolimus
Graft function
Lead sponsor: Hospital Federal de Bonsucesso
Sponsor class: OTHER
First posted: 2011-10-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change from Baseline in Creatinine Clearance at 24 months
timeFrame: baseline and two years
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: baseline and two years
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital federal de Bonsucesso
Study officials:
affiliation: Physician
name: Francisco G Miloski, MD
role: STUDY_CHAIR
affiliation: Chief of the Nephrology Department
name: Tereza Matuck, MD
role: STUDY_CHAIR
affiliation: Head Nurse of The Nephrology Department
name: Regina Sousa
role: STUDY_CHAIR
References: