1. Careggi University Hospital–
Cyclosporine “very low exposure” with Everolimus “high exposure” is associated with better outcomes in renal transplant patients with respect to standard treatment with EC-MPS
Elisabetta Bertoni, Giuseppina Rosso, Aida Larti, Lorenzo Di Maria, Maria Zanazzi, Maurizio Salvadori
RENAL UNIT
Careggi University Hospital–
Florence ,Italy

2. AIM OF THE STUDY PATIENTS AND METHODS
Aim of the study was to compare in cadaveric renal transplant recipients the efficacy of CyA “very low exposure” with Everolimus “high exposure” with respect to CyA “standard exposure” with EC-MPS
PATIENTS AND METHODS
In a randomized, prospective, monocenter, open study, 106 patients were enrolled to receive :
56 pts : Everolimus (to reach C ng/ml) + CyA (to reach C ng/ml )
+ steroids
50 pts : EC-MPS (1440 mg/day) + Cya (to reach C ng/ml) + steroids
- Efficacy was evaluated at 24 months
- Data analyses have been made per protocol
Efficacy was evaluated at 3 and 12 months.
Data analyses have been made per protocol

3. PATIENTS CHARACTERISTICS
EC-MPS
Standard CyA exposure
Everolimus
Very low exposure CyA p
Number 50 56
Recipient age (years)
49.75 ± 12.06
45.70 ± 12.77 NS
Donor age (years)
50.23 ± 16.26
47.40 ± 15.91
Dialysis Duration (months)
43.23 ± 36.1
42.02 ± 31.5
Cold Ischemia Time (hours)
19.80 ± 5.01
18.30 ± 3.67
Mismatches
3.5 ± 1.3
3.364 ± 1.06

4. First period hospitalization (days)
RESULTS I
EC-MPS
Standard CyA exposure
Everolimus
Very low exposure CyA p
First period hospitalization (days)
24.57 ± 12.20
24.77 ± 11.13 NS
BPAR
24%
18.8%
CMV infection
27%
26%

5. RESULTS II 2-YEAR GRAFT SURVIVAL
p = ns

6. RESULTS III CyA dose at 2 years
2.30.64
P <
1.350.49

7. RESULTS IV eGFR (Cockcroft-Gault) at 2 years
p < 0.001
77.78±31.9
54.76±18.76

8. RESULTS V Systolic blood pressure at 2 years
p = NS
129.8±16.23
125.3±13.96

9. RESULTS VII Serum cholesterol at 2 years
p < 0.01
229.747.08
206.742.2
RR =1.72

10. Such therapy was associated with
CONCLUSIONS
Everolimus high exposure associated with very low CyA exposure compared with EC-MPS associated with standard CyA exposure was safe and effective
Such therapy was associated with
Lower incidence of acute rejection and higher 2-year graft survival
Significant higher eGFR at 2 years
Significant higher serum cholesterol levels in E patients at 2 years
24 hours proteinuria was low and similar in both groups

11. BPAR rate at 2 years
P = NS 11