Purpose. The aim of this prospective, exploratory, single center study in kidney transplantation was to compare two immunosuppressive induction regimens: thymoglobulin plus basiliximab (THY) versus basiliximab (BAX).
Methods. Sixty deceased donor kidney transplant recipients were prospectively assigned to THY (30 pts) or BAX (30 pts) and followed up for 1 year. As induction therapy patients assigned to THY received a combination of thymoglobulin (50 mg/day iv from day 0 to day 3, total dose 200 mg) and basiliximab (20 mg iv on day 0 and day 4), while recipients allocated to BAX received only basiliximab (20 mg iv on day 0 and day 4). As maintenance all patients received tacrolimus, MMF and steroids. Steroids in the THY group were selectively withdrawn after 6 months in patients with no previous transplantation, no acute rejection episodes, serum creatinine < 2 mg/dL and proteinuria < 300 mg/24 h.
Results. Demographic characteristics of patients were similar in the two groups. Efficacy and safety parameters after 1 year of follow up are summarized in the table.
|Patient survival (%)||100||100||ns|
|Graft survival (%)||100||97||ns|
|Serum creatinine (mg/dL)||1.5±0.4||1.4±0.4||ns|
|Creatinine clearance (mL/min)||55±20||60±19||ns|
|WBC count (cellx10^3/mL)||6.7±2.5||6.5±1.3||ns|
|Platelet count (cellx10^3/mL)||274±153||197±45||<0.05|
|Total cholesterol (mg/dL)||209±53||210±38||ns|
|Triglycerides level (mg/dL)||185±22||168±125||ns|
|Systolic blood pressure (mmHg)||125±13||129±13||ns|
|Diastolic blood pressure (mmHg)||73±7||78±10||<0.05|
|Dislipidemia on treatment (%)||29||21||ns|
|CMV disease (%)||0||0||ns|
|Tacrolimus C0 (ng/mL)||6.5±1.6||8.3±3.3||<0.05|
|Tacrolimus C2 (ng/mL)||11.3±4.9||14.4±5.6||<0.05|
|MMF daily dose (mg)||989±53||947±158||ns|
|Steroids daily dose (mg)||2.4±2.1|