Desensitization With Bortezomib Before a Living Kidney Donation (VELDON)

September 28, 2016 updated by: Assistance Publique - Hôpitaux de Paris
The investigators plan to study the role of bortezomib for desensitizing patients awaiting a living kidney donation who have a titer of Donor Specific anti human leucocyte antigen (HLA) Antibody (DSA) between 1000 and 3000 MFI with a pilot study of 10 patients recruited in 4 hospital in FRANCE.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators plan to study the role of bortezomib for desensitizing patients awaiting a living kidney donation who have a titer of Donor Specific anti HLA Antibody (DSA) between 1000 and 3000 MFI with a multicentre pilot study of 10 patients. The effect of bortezomib will be observed up to 6 month after bortezomib treatment prior to transplantation and 12 month after transplantation if performed. The living kidney donation will be performed only if the DSA level drops below 1000 MFI which means an efficacy of the desensitization.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le KREMLIN-BICETRE, France, 94 275
        • Recruiting
        • Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hélène François, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient between 18 and 70 years old
  • awaiting a living kidney donation
  • but with a least one DSA titer between 1000 MFI and 3000 MFI

Exclusion Criteria:

  • positive cell dependent cytotoxicity CM,
  • DSA level above 3000 MFI
  • and every condition that is a contre indication for bortezomib treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bortezomib
Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation
Drug: Bortezomib
Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with Donor specific antibody (DSA) level below 1000MFI authorizing the living kidney donation
Time Frame: up 6 months after bortezomib treatment and before transplantation
Bortezomib treatment should allow a decrease in DSA level below a threshold level authorizing the living kidney donation with minimal risk
up 6 months after bortezomib treatment and before transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute and relative differences of the DSA titer ans antiHLA non DSA titer bortezomib treatment
Time Frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Safety and efficacy of bortezomib treatment 12 months after transplantation if performed, if not 6 month after the last bortezomib injection
12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Frequency of clinical symptoms and anomalies
Time Frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Safety and efficacy of bortezomib treatment
12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Frequency of side effects
Time Frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Safety and efficacy of bortezomib treatment
12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Frequency of anomalies at the standard blood tests
Time Frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Safety and efficacy of bortezomib treatment
12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Frequency of anomalies at the total lymphocyte count and phenotyping
Time Frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Safety and efficacy of bortezomib treatment
12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Frequency of proteinuria and anomalies at the glomerular filtration rate
Time Frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Safety and efficacy of bortezomib treatment
12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Proportion of transplanted patients
Time Frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Safety and efficacy of bortezomib treatment 12 months after transplantation if performed, if not 6 month after the last bortezomib injection
12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Incidence of biopsy proven acute rejection and chronic rejection
Time Frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Safety and efficacy of bortezomib treatment 12 months after transplantation if performed, if not 6 month after the last bortezomib injection
12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Hélène François, MD, PhD, Assistance Publique Hôpitaux de Paris - Bicêtre Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ANTICIPATED)

March 1, 2017

Study Completion (ANTICIPATED)

March 1, 2018

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 26, 2013

First Posted (ESTIMATE)

April 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P110147
  • 2012-001988-78 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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