. 2019 May 7;32(8):775–788. doi: 10.1111/tri.13436

Table 1.

Randomized controlled trials in late and/or chronic ABMR after kidney transplantation

Author, year	Trial design	Inclusion criteria	Treatment	Patients	Immunosuppression	Follow‐up	Major EP	Major results
Kulkarni, 2017 16	Single centre nonblinded RCT	HLA‐DSA+, 20% eGFR decline upon 12 months	Eculizumab, 600 mg/week for 4 weeks; 900 mg every 2 weeks for 26 weeks	Treatment: n = 10 Control: n = 5	Not specified	1 year	Primary EP: eGFR decline Secondary EP: acute rejection; treatment failure (death, graft loss, loss to follow‐up or withdrawal from trial); biopsies at 3, 6 and 12 months, DSA MFI and C1q fixation	Marginal improvement of eGFR trajectory (P = 0.09); no effect on morphological and molecular biopsy results
Moreso, 2018 35	Multicentre placebo‐controlled RCT^a	HLA‐DSA+, chronic ABMR (cg > 0)	IVIGx4 (0.5 g/kg) every 3 weeks RTX (375 mg/m²) 1 week after the last IVIG infusion	Treatment: n = 13 Placebo: n = 12	Tac/MMF Tac C0: 5–10 ng/ml	1 year	Primary EP: eGFR decline Secondary EP: proteinuria, biopsies at 12 months, DSA MFI	No effect on eGFR decline, biopsy results and DSA‐MFI; no differences in adverse events
Eskandary, 2018 34	Single centre placebo‐controlled RCT	HLA‐DSA+, late ABMR after >180 days	Bortezomib (two cycles; each four injections, 1.3 mg/m²; 3‐month interval)	Treatment: n = 21 Placebo: n = 23	Triple immunosuppression Tac C0: 7–10 ng/ml CyA C0: 80–120 ng/ml	2 years	Primary EP: eGFR slope Secondary EP: proteinuria; biopsies at 24 months, DSA MFI	No effect on eGFR decline, biopsy results and DSA MFI Higher rate of SAEs

Author, year

Trial design

Inclusion criteria

Treatment

Patients

Immunosuppression

Follow‐up

Major EP

Major results

Kulkarni, 2017 16

Single centre nonblinded RCT

HLA‐DSA+, 20% eGFR decline upon 12 months

Eculizumab, 600 mg/week for 4 weeks; 900 mg every 2 weeks for 26 weeks

Treatment: n = 10

Control: n = 5

Not specified

1 year

Primary EP: eGFR decline

Secondary EP: acute rejection; treatment failure (death, graft loss, loss to follow‐up or withdrawal from trial); biopsies at 3, 6 and 12 months, DSA MFI and C1q fixation

Marginal improvement of eGFR trajectory (P = 0.09); no effect on morphological and molecular biopsy results

Moreso, 2018 35

Multicentre placebo‐controlled RCT^a

HLA‐DSA+, chronic ABMR (cg > 0)

IVIGx4 (0.5 g/kg) every 3 weeks

RTX (375 mg/m²) 1 week after the last IVIG infusion

Treatment: n = 13

Placebo: n = 12

Tac/MMF

Tac C0: 5–10 ng/ml

1 year

Primary EP: eGFR decline

Secondary EP: proteinuria, biopsies at 12 months, DSA MFI

No effect on eGFR decline, biopsy results and DSA‐MFI; no differences in adverse events

Eskandary, 2018 34

Single centre placebo‐controlled RCT

HLA‐DSA+, late ABMR after >180 days

Bortezomib (two cycles; each four injections, 1.3 mg/m²; 3‐month interval)

Treatment: n = 21

Placebo: n = 23

Triple immunosuppression

Tac C0: 7–10 ng/ml

CyA C0: 80–120 ng/ml

2 years

Primary EP: eGFR slope

Secondary EP: proteinuria; biopsies at 24 months, DSA MFI

No effect on eGFR decline, biopsy results and DSA MFI

Higher rate of SAEs

ABMR, antibody‐mediated rejection; DSA, donor‐specific antibody; eGFR, estimated glomerular filtration rate; EP, endpoint; MMF, mycophenolate mofetil; MFI, mean fluorescence intensity; RCT, randomized controlled trial; SAE, severe adverse event; Tac, tacrolimus.

Planned sample size: 25 patients per group (not achieved because of budgetary constraints and slow patient recruitment).