AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Voluntary written informed consent
* Age \>18 years
* Functioning living or deceased donor allograft after ≥365 days post-transplantation
* eGFR \>30 ml/min/1.73 m2
* Detection of HLA class I and/or II antigen-specific antibodies (preformed and/or de novo DSA).
* Acute/active or chronic/active ABMR (±C4d in PTC) according to Banff 2013/2015
* Molecular ABMR score (ABMRpm) ≥0.2
Exclusion Criteria:
* Patients actively participating in another clinical trial
* Age ≤18 years
* Female subject is pregnant or lactating
* 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
* Acute rejection treatment \<3 month before screening
* Acute deterioration of graft function (eGFR decline within 1-3 months \>25%)
* Nephrotic range proteinuria \>3500 mg/g protein/creatinine ratio
* Active viral, bacterial or fungal infection precluding intensified immunosuppression
* Active malignant disease precluding intensified immunosuppressive therapy
* Abnormal liver function tests (ALT, AST, bilirubin \> 1.5 x upper limit of normal)
* Other significant liver disease
* Latent or active tuberculosis (positive QuantiFERON-TB-Gold test, Chest X-ray)
* Administration of a live vaccine within 6 weeks of screening
* Neutropenia (\<1 G/L) or thrombocytopenia (\<100 G/L)
* History of gastrointestinal perforation, diverticulitis, or inflamm…
What they're measuring
1
Number of adverse events and severe adverse events (AE's, SAE's)