Comparison Between Bortezomib and Rituximab Plus Plasmapheresis in AMR

Shahid Beheshti University of Medical Sciences

Status: Completed

Conditions: Antibody-mediated Rejection

Treatments: Drug: Bortezomib

Study type: Interventional

Funder types: Other

Identifiers

NCT03737136

SMBU11254/B

Details and patient eligibility

About

Chronic-active antibody-mediated rejection (cAMR) due to de novo or pre-formed donor specific antibody (DSA) is currently considered the main cause of long-term allograft losses.Based on the aim of reducing or eliminating DSA, some proposed different therapeutic regimens for cAMR treatment. All of these protocols were derived from previous experience using acute antibody-mediated rejection and desensitization protocols, and mainly consisted of steroids, plasma exchange (PE), IVIG and RTX in various modalities. More recently, bortezomib was also proposed.To evaluate the role of a therapeutic regimen with plasma exchange, intravenous immunoglobulins and rituximab with or without Bortezomib in chronic-active antibody-mediated rejection (cAMR) settings this study designed.

Full description

20 kidney transplant recipients (KTRs) with a diagnosis of cAMR in a prospective randomized clinical trial will be recruited in two arms

: ten KTRs treated with plasmapheresis, intravenous immunoglobulins and rituximab (PE-IVIG-RTX group) vs 10 patients receiving the same therapy plus Bortezomib. Differences between transplanted kidney survival and functional outcomes 6 mo after diagnosis and histological features and donor-specific antibody (DSA) characteristics (MFI ) will be investigated between two arms.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients presented with renal biopsy demonstrating ABMR in the absence of T-cell-mediated rejection

Exclusion criteria

• Mixed AMR and T cell rejection
• do not sign the consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Plasmapheresis

No Intervention group

Description:

5 Sessions Plasmapheresis and 100 mg/kg Intra venous immunoglobulin at the end of each session and one dose 375mg/m2 rituximab at the end of last session

Plasmapheresis plus Bortezomib

Active Comparator group

Description:

Drug 5 Sessions Plasmapheresis and 100 mg/kg Intra venous immunoglobulin at the end of each session and one dose 375ml/m2 rituximab at the end of last session plus bortezomib Injections 1.3mg/m2 intravenously on days 1, 4, 8, and 11

Treatment:

Drug: Bortezomib