Efficacy and Safety of Eculizumab for Treatment of Antibody-mediated Rejection Following Renal Transplantation

Inclusion Criteria:

1. Adult renal transplant recipients, men and women between 18 and 75 years of age.

2. Any patient with acute graft dysfunction (elevation of creatinine above post
transplant nadir)

AND, two out of three, of the following Inclusion Criteria:

3. Presence of circulating anti HLA antibody (DSA).

4. Histological findings compatible with Banff Class II or III AMR on transplant biopsy.

5. Peritubular capillary c4d positivity on transplant biopsy.

Exclusion Criteria:

1. Patients that have received eculizumab prior to enrolling in the study.

2. Patients with ongoing non-acute antibody mediated rejection.

3. Patients with predominantly chronic antibody mediated rejection or interstitial
fibrosis/tubular atrophy.

4. History of severe cardiac disease (e.g., New York Heart Association [NYHA] Functional
Class III or IV, myocardial infarction ≤ 6 months of randomization, ventricular
tachyarrhythmias requiring ongoing treatment, unstable angina or other significant
cardiovascular diseases)

5. Prior splenectomy

6. Has a known bleeding disorder

7. Has any active bacterial or other infection which is clinically significant in the
opinion of the Investigator and is a contraindication to transplantation

8. Has participated in any other investigational drug study or was exposed to an
investigational drug or device within 30 days of screening

9. Has received rituximab (Rituxan®) ≤ 3 months prior to screening

10. Has received bortezomib (Velcade®) ≤ 3 months prior to screening

11. Has received alemtuzumab (Campath®) ≤ 6 months prior to screening

12. Need for concurrent treatment with anti thymocyte globulin (Thymoglobulin®)

13. Hypersensitivity to murine proteins or to one of the product excipients

14. History of illicit drug use or alcohol abuse within the previous year

15. Unresolved meningococcal disease

16. Pregnancy or lactation

17. Current cancer or a history of cancer within the 5 years prior to screening with the
exception of patients who have successfully treated non-metastatic basal or squamous
cell carcinoma of the skin; carcinoma in situ of the cervix; or breast carcinoma in
situ

18. Any medical condition that, in the opinion of the Investigator, might interfere with
the patient's participation in the study, poses an added risk for the patient, or
confounds the assessment of the patient Active infection with Hepatitis B (HBV),
Hepatitis C (HCV) or human immunodeficiency virus (HIV)