Comparison Between Bortezomib and Rituximab Plus Plasmapheresis in AMR

NCT03737136 | Completed DMC

• 1 other identifier: SMBU11254/B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Antibody-mediated Rejection

Keywords

transplantation; plasmapheresis

Outcome Measures

Primary Outcomes (1)

• graft survival

  Glomerular Filtration Rate

  at month 6 following diagnosis

Secondary Outcomes (3)

• Renal functional tests

  at month 6 following diagnosis

• Changes in Grading of antibody mediated rejection regarding Banff criteria in pathology

  at month 6 following diagnosis

• DSAs-MFI

  at month 6 following diagnosis

Study Arms (2)

Plasmapheresis

NO INTERVENTION

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

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

Drug: Bortezomib

Interventions

Bortezomib DRUG

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

Also known as: Velcade

Plasmapheresis plus Bortezomib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

SBMU

Tehran, Iran

Location

MeSH Terms

Interventions

Bortezomib

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shahid Beheshti MU sbmu

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 9, 2018
• Study Start: November 1, 2019
• Primary Completion: May 30, 2024
• Study Completion: September 1, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)