Comparison Between Bortezomib and Rituximab Plus Plasmapheresis in AMR

  • STATUS
    Recruiting
  • End date
    Oct 1, 2022
  • participants needed
    20
  • sponsor
    Shahid Beheshti University of Medical Sciences
Updated on 24 March 2022

Summary

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.

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.

Details
Condition Antibody-mediated Rejection
Treatment Bortezomib
Clinical Study IdentifierNCT03737136
SponsorShahid Beheshti University of Medical Sciences
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
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