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Bortezomib in Rejection of Kidney Transplants

NCT02201576 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-13

No results posted yet for this study

Summary

The purpose of the study is to assess the efficacy of bortezomib, in association with steroids, plasma exchange, and polyclonal intravenous immunoglobulins, in the treatment of chronic antibody mediated rejection due to donor specific anti-HLA antibodies, in kidney transplant recipients

Conditions

  • Chronic Antibody-mediated Transplant Rejection

Interventions

DRUG

Bortezomib

1. Five plasma exchanges +0.1 g/kg of intravenous immunoglobulins at the end of each course 2. two cycles of bortezomib (1.3 mg/m2 IV at day-1, day-4, day-8, day-11) + oral dexamethasone (20 mg po at day-1, day-4, day-8, day-11) 3. four courses of polyclonal intravenous immunoglobulins every three weeks (2g/kg, the first two courses are performed simultaneously with the two bortezomib cycles)

DRUG

Plasma exchanges and intravenous immunoglobulins

1. Five plasma exchanges +0.1 g/kg of intravenous immunoglobulins at the end of each course 2. four courses of polyclonal intravenous immunoglobulins every three weeks (2g/kg) 3. oral dexamethasone (20 mg po at day-1, day-3, day-5, day-7 of the two first intravenous immunoglobulins courses)

Sponsors & Collaborators

  • Fondation Centaure

    collaborator OTHER

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Christophe Legendre, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • Renaud Snanoudj, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-11
Primary Completion
2020-07-16
Completion
2020-07-16

Countries

  • France

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 NCT02201576 on ClinicalTrials.gov