TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients

Inclusion Criteria:

1. The subject has given their written informed consent to participate in the study

2. Recipient of living donor or deceased donor kidney transplant

3. Age ≥18 years

4. At least 6 months post-transplantation at randomization

5. Biopsy-proven diagnosis of late active or chronic active ABMR (≥ 6 months aftertransplantation) according to the Banff 2022 criteria in index biopsy

6. eGFR ≥20 ml/min/1.73 m2

7. Epstein-Barr Virus (EBV) IgG-positive

8. For female participants of childbearing potential:

• use of adequate contraception and a negative pregnancy test

9. Subject known to have COVID-19 previously must meet all of the following conditions:

• Asymptomatic for at least 1 month before the start of screening

• Re-established on background immunosuppressants for at least 1 month prior tothe randomization

Exclusion Criteria:

1. Recipient of multi-organ transplants

2. De novo or recurrent renal disease that is considered to be the predominant cause ofthe current graft dysfunction

3. Active viral infections such as BK virus (BKV), cytomegalovirus (CMV), EBV,COVID-19, hepatitis C virus (HCV) or hepatitis B virus (HBV) infections based onpolymerase chain reaction (PCR) testing

4. Ongoing serious infections as per Investigator's opinion

5. History of recurrent infections requiring hospitalization

6. Active tuberculosis (TB)

7. Latent untreatedTB (positive QuantiFERON-TB-Gold test, Chest X-ray)

8. Abnormal liver function tests alanine transaminase (ALT), aspartate transaminase (AST), bilirubin > 1.5 x upper limit of normal)

9. Other significant liver disease as per Investigator's opinion

10. Neutropenia (<2 x109/L) or thrombocytopenia (<100 x109/L)

11. Signs of post-transplant lymphoproliferative disorder

12. Signs of malignancy. Exceptions are basal cell carcinoma/squamous cell carcinoma ornon-malignant melanoma

13. History of malignancy, unless subject has been considered to have fully recoveredfrom malignancy since > 2 years, without any signs of relapse

14. History of diverticulitis, inflammatory bowel disease or gastrointestinalperforation

15. Ongoing alcohol or illicit substance abuse

16. Serious medical or psychiatric illness likely to interfere with participation in thestudy as per Investigator's opinion

17. Mental inability or reluctance that results in difficulties in understanding themeaning of study participation

18. Woman of childbearing potential who is unwilling/unable to use an acceptable methodto avoid pregnancy for the entire study period and for up to 8 weeks after the lastdose of study drug

19. Woman with a positive pregnancy test or who is pregnant or breastfeeding

20. Current or recent (within last 3 months) participation in another clinical drugtrial