Thymoglobulin Plus Basiliximab vs Basiliximab as Induction Therapy in Deceased Donor Kidney Transplant Recipients Treated with Tacrolimus and Mycophenolate Mofetil: 1-Year Results of a Prospective Clinical Trial
Surgery - Renal Transplantation, Catholic University, Rome, Italy
Meeting: 2013 American Transplant Congress
Abstract number: C1339
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 Steroids in the THY group were selectively withdrawn after 6 months in patients with no previous transplantation, no acute rejection episodes, serum creatinine 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.
| THY | BAX | p | |
| Patients (#) | 30 | 30 | |
| Patient survival (%) | 100 | 100 | ns |
| Graft survival (%) | 100 | 97 | ns |
| BPAR (%) | 10 | 14 | ns |
| Serum creatinine (mg/dL) | 1.5±0.4 | 1.4±0.4 | ns |
| Creatinine clearance (mL/min) | 55±20 | 60±19 | ns |
| Proteinuria (g/24h) | 0.1±0.2 | 0.2±0.4 | ns |
| Hemoglobin (g/dL) | 12.7±1.4 | 13.6±1.7 | 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 |
| NODAT (%) | 3 | 7 | ns |
| CMV disease (%) | 0 | 0 | ns |
| PVAN (%) | 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 |