1. EXPERIENCE WITH ALEMTUZUMAB IN KIDNEY TRASPLANTATION
Nestor Pedraza, Yenny Baez, Fernando Giron
Transplant Surgeons
Colombiana de Trasplantes
Bogota, Colombia

3. INDUCTION THERAPY

4. INTRODUCTION
Campath-1H is a humanized monoclonal antibody directed against CD52 glycoprotein expressed in approximately 95% of lymphocyte in peripheral blood; CD52 is not present in granulocytes, platelets, erythrocytes, or hematopoietic stem cells
Its mechanism of action includes complement-mediated cytolysis, antibody-mediated cytotoxicity and apoptosis

5. MATERIALS AND METHODS
Descriptive study of a prednisone-free immunosuppression protocol for kidney transplant recipients who received alemtuzumab as induction agent

6. p < 0,05 (yates corrected)
STATISTICAL ANALYSES
EPI INFO v 1.6
p < 0,05 (yates corrected)

7. GROUP 1

8. MATERIALS AND METHODS
100 patients received kidney transplant from living or cadaveric donor
San Rafael Clinic and Marly Clinic
Recipients > 14 y.o.
Follow-up Time: 1 year
Induction: Alemtuzumab 30 mg IV

9. IMMUNOSUPRESION AND MEDICAL THERAPEUTICS
Pre-medication
Clemastine 2 mg and acetaminophen 1 g
Methylprednisolone 500mg, 250mg, 125mg
Manteinance
Anticalcineurinic Inhibitor. Target levels
CSA C ng/ml
TAC C0 5-7 ng/ml
MMF (1500 mg/d) or Mycophenolic acid (MPA) (1080 mg/d)

10. PROPHYLAXIS Cephalosporin first or second generation
Valganciclovir 450 mg qd for 3 months
Nistatine 1 million U tid for 2 months
Trimethoprim-sulfamethoxazole 480 mg 2x/week for 6 months

11. DEMOGRAPHICS CHARACTERISTICS
Age
M: 38.5
m: 36.5
/- 23 years
Range
15 – 68 years
Gender (M:F)
56% : 44%
Donor Source
Cadaveric
Living
94% 6%
Pediatric recipients
n: 100

12. * ACUTE REJECTION TIME (month) INCIDENCE CUMULATIVE RATE 1 0 % 3 4 % 6
5 %
9 % 12
8 %
17 %
* All ACR were biopsy proven

13. REJECTION TYPE n = 17 Banff 1 a 9 (53%) Banff 1 b 6 (35%) Banff 2 a
1 (6%)
Banff 2 b
Banff 3
Humoral

14. INFECTIOUS COMPLICATIONS
INFECTIONS
23%
UTI
20%
OTHERS INFECTIONS 3%

15. CONCLUSIONS
Alemtuzumab may be given as a single dose, low cost, easy administration and allow to use prednisone-free immunosuppression
Acute rejection for the first month was 0%
A raise in acute rejection incidence after 3rd month
Most acute rejections were mild

16. WHAT DID WE BELIEVE?
Higher rate of later rejection ( 3-6 month) reflects inadequate maintenance immunosuppression exposure when lymphocyte repopulation would be anticipated

17. GROUP 2

18. MATERIALS AND METHODS
100 patients received kidney transplant from living or cadaveric donor
San Rafael and Marly Clinic
Recipients >14 y.o.
Follow-up Time: 1 year
Induction: Alemtuzumab 30 mg IV

19. IMMUNOSUPRESION AND MEDICAL THERAPEUTICS
Pre-medication
Clemastine 2 mg and acetaminofen 1 g
Methylprednisolone 500mg, 250mg, 125mg
Manteinance
Anticalcineurinic Inhibitor. Target levels
CSA C ng/ml
TAC C0 5-7 ng/ml

20. MANTEINANCE IMMUNOSUPPRESSION
Manteinance changes
INCREASE MMF OR MPA: FULL DOSE
2 g or 1.4 g/day since 3rd month

21. PROPHYLAXIS Cephalosporin first or second generation
Valganciclovir 450 mg qd for 3 months
Nistatine 1 million U tid for 2 months
Trimethoprim-sulfamethoxazole 480 mg 2x/week for 6 months

22. DEMOGRAPHICS CHARACTERISTICS
Group 1
Group 2
* Age
M: 38.5
m: 36.5
/- 23 years
M: 39.45
m: 40.5
/- 25 years
Range
15 – 68 years
14 – 63 years
Gender (M:F)
56% : 44%
58% : 42%
Donor Source
Cadaveric
Living
94% 6%
86%
14%
Pediatric recipients 3%
* p> 0,65

23. * ACUTE REJECTION TIME (month) INCIDENCE CUMULATIVE RATE 1 0 % 3 5 % 6
1 %
6 % 12
2 %
8 %
* All ACR were biopsy proven

24. REJECTION TYPE n = 8 Banff 1 a 3 (37,5%) Banff 1 b Banff 2 a 1 (12,5%)
Banff 3
Humoral

25. INFECTIOUS COMPLICATIONS
INFECTIONS
11%
UTI 9%
OTHERS INFECTIONS 2%

26. CONCLUSIONS

27. ACUTE REJECTION INCIDENCE
p< 0,04
o.r. 0,12 (0,01 – 0,94)

28. ACUTE REJECTION CUMULATIVE RATE
% Incidence
p< 0,05
o.r. 0,37 (0,13 – 0,95)

29. The increase in the maintenance immunosuppression regimen after third month is related with the reduction of acute rejection in kidney transplant