MedTrace Logo

Comparison Between Bortezomib and Rituximab Plus Plasmapheresis in AMR

NCT03737136 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-08

No results posted yet for this study

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

Interventions

DRUG

Bortezomib

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

Sponsors & Collaborators

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Principal Investigators

  • Shahid Beheshti MU sbmu · Shahid Beheshti University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2024-05-30
Completion
2025-09-01

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03737136 on ClinicalTrials.gov