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OpenTrials
Completed

NCT Number: NCT03737136

Comparison Between Bortezomib and Rituximab Plus Plasmapheresis in AMR

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.

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Key information

Conditions

Antibody-mediated Rejection

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SBMU

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bortezomib

Drug

one cycle of bortezomib (each cycle: 1.3mg/m2 intravenously on days 1, 4, 8, and 11)

Other names: Velcade

Primary outcomes

  1. graft survival

    Time frame: at month 6 following diagnosis

    Glomerular Filtration Rate

Secondary outcomes

  1. Renal functional tests

    Time frame: at month 6 following diagnosis

    Serum Cr

  2. Changes in Grading of antibody mediated rejection regarding Banff criteria in pathology

    Time frame: at month 6 following diagnosis

    kidney biopsy

  3. DSAs-MFI

    Time frame: at month 6 following diagnosis

    Serum Test

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

Comparison Between Rituximab + PLX + IVIG With and Without Bortezomib in the Treatment of Antibody Mediated Kidney Transplanted Rejection

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Nov 9, 2018
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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