Table 2.
Trial design | Inclusion criteria | Test therapeutics | Other Immuno suppression | Patients | Follow up | Major results | Ref |
---|---|---|---|---|---|---|---|
single center, open-label case study, historical control | chronic ABMR, DSA+, TG | Tocilizumab (8 mg/kg monthly, maximal dose 800 mg for 6–25 months) | Tac/MMF/Pred | 36 | 6 years | reduction in DSAs and stabilization of renal function at 2 years; graft survival rate of 80%, patient survival rate of 91% at 6 years | Choi J, et al. (126) |
randomized controlled trials | ABMR, DSA+ | C1 INH (5000 U on day 1 of ABMR, 2500 U on days 3, 5, 7, 9, 11, and 13) add-on standard of care (PP+IVIG+/- anti‐CD20) | n/a | 18 (treatment: n=9; placebo: n=9) | 6 months | reduction of transplant glomerulopathy | Montgomery RA, et al. (127) |
single center, observational study, historical control | refractory active ABMR with acute allograft dysfunction, DSA>3000 MFI, g+ptc≥2 |
C1 INH (20 units/kg on days 1, 2, and 3 and then twice weekly; IVIG at 2 g/kg every month for 6 months |
Tac/MMF/Pred | 6 | 6 months | improvement in eGFR, reduced DSA; no change in histological features | Viglietti D, et al. (128) |
randomized controlled trials | adult patient receiving a kidney transplant | Belimumab (10 mg/kg on day 0, 14, and 28, and then every 4 weeks for a total of 7 infusions) | Tac/MMF/Pred | 28 (treatment: n=14; placebo: n=14) | 6 months | similar proportions of adverse events; no change in the number of naive B cells | Banham GD, et al. (129) |
TG, transplant glomerulopathy; Tac, tacrolimus; MMF, mycophenolate mofetil; Pred, prednisone; n/a, not available.