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. 2021 May 20;12:661643. doi: 10.3389/fimmu.2021.661643

Table 2.

Clinical trials - new therapies for chronic ABMR after kidney transplantation.

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.