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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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