Table 1 Inclusion and exclusion criteria
Inclusion criteria | 1. Voluntary written informed consent |
2. Age > 18 years | |
3. Functioning kidney allograft after ≥ 365 days after transplantation | |
4. eGFR > 30 mL/min/1.73 m2 | |
5. Slow deterioration of graft function or proteinuria | |
6. Detection of HLA class I and/or II DSA (preformed and/or de novo) | |
7. Active or chronic/active ABMR (± C4d in peritubular capillaries) | |
8. Molecular ABMR score ≥ 0.2 | |
Exclusion criteria | 1. Patients actively participating in another clinical trial |
2. Age ≤ 18 years | |
3. Female participants are pregnant or lactating | |
4. Index biopsy results: | |
T-cell-mediated rejection classified Banff grade ≥ I | |
De novo or recurrent severe thrombotic microangiopathy | |
Polyoma virus nephropathy | |
De novo or recurrent glomerulonephritis | |
5. Acute rejection treatment < 3 months before screening | |
6. Acute deterioration of graft function (> 25% eGFR decline within 1–3 months) | |
7. Nephrotic range proteinuria > 3500 mg/g protein/creatinine ratio | |
8. Active viral, bacterial, or fungal infection precluding intensified immunosuppression | |
9. Active malignant disease precluding intensified immunosuppressive therapy | |
10. Patients with evidence of malignant disease, or malignancies diagnosed within the previous 5 years (with the exception of local basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured) | |
11. Abnormal liver function tests (ALT, AST, bilirubin > 1.5× ULN) | |
12. Other significant liver disease | |
13. Latent or active tuberculosis (positive QuantiFERON-TB-Gold test, Chest X-ray) | |
14. Administration of a live vaccine within 6 weeks of screening | |
15. Neutropenia (< 1 G/L) or thrombocytopenia (< 100 G/L) | |
16. History of gastrointestinal perforation, diverticulitis, or inflammatory bowel disease | |
17. Allergy against proton pump inhibitors | |
16. History of alcohol or illicit substance abuse | |
17. Serious medical or psychiatric illness likely to interfere with study participation | |
18. Prisoners or individuals who are involuntarily incarcerated | |
19. Individuals who depended on the sponsor, the study site, or the investigators | |
20. Patients with known hypersensitivity to any constituent of the product | |
21. Patients with history of or currently active primary or secondary immunodeficiency |