Stopped: Stopped at start of COVID-19 pandemic - non-feasible
United Kingdom3 participantsStarted 2019-07-17
Plain-language summary
This trial evaluates the addition of rituximab to standard of care in the treatment of antibody-mediated rejection in kidney transplant patients. The trial will involve adults and children. Half of participants will receive standard of care (methylprednisolone, intravenous immunoglobulin and plasma exchange), while the other half will receive standard of care and rituximab.
Who can participate
Age range5 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing and able to give written informed consent by patient aged 16 years and over; or by a parent or legal guardian for patients who are under 16 years old
* 5 years old or older
* A diagnosis of acute AMR as defined by:
* The presence of ≥1 donor specific antibodies (DSA)
* An adequate renal transplant biopsy with histological features consistent with active AMR with no evidence of chronicity as defined by the Banff histological classification of allograft pathology:
* If C4d positive (2 or 3):
* v score ≥1 and/or
* g score ≥1 and/or
* thrombotic microangiopathy and/or
* ptc score ≥1
* or if co-existent cellular rejection, a g score of ≥1 OR
* If C4d negative (0 or 1):
* microcirculation inflammatory score (g + ptc) ≥2
* or if co-existing cellular rejection, a g score ≥1 and (g + ptc) ≥2 AND
* Chronic glomerulopathy (cg) score 0 or 1a
* Tubulo-interstitial fibrosis \<50% and glomerular obsolescence \<50%
Exclusion Criteria:
* Patients who have received an ABO incompatible transplant
* Patients who have received rituximab as part of induction or post-transplant for any other indications (e.g. recurrent focal and segmental glomerular sclerosis)
* Patients who have completed PEX treatment prior to the index biopsy on the suspicion of acute AMR in the absence of histology
* Have active infection including bacterial, viral (including CMV (cytomegalovirus) and EBV (Epstein-Barr virus)), fungal or tuberculosis, which in the investigator's opinion could af…
What they're measuring
1
Allograft Survival as assessed by statistical model