Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After Kidney Transplantation in Adults
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Change from Baseline in Creatinine Clearance at 24 months [ Time Frame: baseline and two years ] [ Designated as safety issue: No ]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.
- Number of Participants with Adverse Events [ Time Frame: baseline and two years ] [ Designated as safety issue: Yes ]The secondary objective is to demonstrate the safety by comparing rejection episodes, graft loss, infection, cancer and death in the control group
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Group will switch calcineurin inhibitor to everolimus within 1 day (overnight).
Other Name: Certican
|Active Comparator: calcineurin inhibitor||
Drug: calcineurin inhibitor
Group will maintain their initial immunosuppression therapy with calcineurin inhibitor
Other Name: Tacrolimus, Cyclosporin, NeoOral, Prograf
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.
|Contact: Deise BM Carvalho, MD||+55 (21) email@example.com|
|Hospital federal de Bonsucesso||Not yet recruiting|
|Rio de Janeiro, Brazil, 21041-030|
|Study Chair:||Francisco G Miloski, MD||Physician|
|Study Chair:||Tereza Matuck, MD||Chief of the Nephrology Department|
|Study Chair:||Regina Sousa||Head Nurse of The Nephrology Department|