Table 2.
Planned and ongoing, trials evaluating new therapies in late and/or chronic ABMR after kidney transplantation
| Treatment | Participating centres | Design; interventions | ClinicalTrials.gov |
|---|---|---|---|
| Anti‐IL‐6 antibody | Los Angeles, CA (USA) 70 | Single arm trial (n = 10): clazakizumab (6 months) | NCT03380377 |
| Anti‐IL‐6 antibody | Vienna (Austria); Berlin (Germany) 68, 69 | RCT (n = 20): clazakizumab vs. placebo (part A month 0–3); clazakizumab (open‐label part B: month 4–12) | NCT03444103 |
| Anti‐IL‐6 antibody | USA, Europe, Australia 71 (IMAGINE trial) | RCT (IMAGINE trial; n = 350): clazakizumab versus placebo (260 weeks) | NCT03744910 |
| DFPP | Genoble (France) 83 | Open‐label RCT (n = 16): PP + RTX vs. DFPP + RTX (11 days treatment course; 1 year follow‐up) | NCT03436134 |
| Bortezomib – combined regimen | France 53 (TRIBUTE trial) | RCT (n = 100): bortezomib + PP + IVIG + dexamethasone vs. PP + IVIG + dexamethasone | NCT02201576 |
| Bortezomib – combined regimen | Tehran (Iran) 54 | RCT (n = 20): bortezomib + PP + IVIG + RTX vs. PP + IVIG + RTX | NCT03737136 |
| Corticotropin | Birmingham, Alabama (USA), Baltimore, Maryland (USA) 89 | Single‐arm trial (n = 20): corticotropin (24 weeks) in addition to centre‐specific standard therapy | NCT02546492 |
| Mesenchymal stem cells | Ljubljana (Slovenia) 90 | Single‐arm (n = 10): mesenchymal stem cells + PP, IVIG and steroids | NCT03585855 |
DFPP, double filtration plasmapheresis; IL‐6, interleukin‐6; IVIG, intravenous immunoglobulin; PP, plasmapheresis; RCT, randomized controlled trial; RTX, rituximab.