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Table 1 Inclusion and exclusion criteria

From: Tocilizumab in chronic active antibody-mediated rejection: rationale and protocol of an in-progress randomized controlled open-label multi-center trial (INTERCEPT study)

Inclusion Criteria

Exclusion Criteria

1. Written informed consent

2. Recipient of living donor or deceased donor kidney transplant

3. Age ≥18

4. At least 12 months post-transplant at randomization

5. Biopsy-proven diagnosis of caAMR (not older than 1 year at randomization)

6. eGFR ≥20 ml/min/1.73 m2 (not older than 1 month at randomization)

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

8. Female participants of childbearing potential: use of adequate contraception and a negative pregnancy test

9. Subjects with previous COVID-19 infection must meet the following conditions:

- Asymptomatic > 1 month before the start of screening

- Re-established immunosuppressants > 2 weeks prior to the start of screening

1. Recipient of multi-organ transplants

2. eGFR <20 ml/min/1.73 m2

3. De novo or recurrent renal disease, if it is considered to be the predominant cause of current graft dysfunction

4. Active viral infectionsa

5. Ongoing serious infections

6. History of recurrent infections requiring hospitalization

7. Signs of post-transplant lymphoproliferative disorder

8. History of tuberculosis, active or latent disease

9. Abnormal liver function tests (ALT, AST or bilirubin > 1.5 x upper limit of normal)

10. Other significant liver disease

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

12. Signs of malignancy. Exceptions are basal or squamous cell carcinoma or non-malignant melanoma

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

14. History of diverticulitis, diverticulosis, gastrointestinal perforation, or inflammatory bowel disease

15. Substance abuse

16. Serious medical or psychiatric illness

17. Mental inability, reluctance, or difficulties in understanding the informed consent

18. Woman of childbearing potential not applying inclusion criteria number 8

19. Current or recent (within last 3 months) participation in another clinical drug trial

  1. Details are provided under Eligibility criteria in Methods section
  2. ALT Alanine transaminase, AST Aspartate transaminase, caAMR Chronic active antibody-mediated rejection, eGFR Estimated glomerular filtration rate
  3. aSuch as BK virus (BKV), cytomegalovirus (CMV), SARS COV-2 (COVID-19), EBV, hepatitis C virus (HCV) or hepatitis B virus (HBV) infections, based on polymerase chain reaction (PCR) testing