NCT01842074

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 8, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

4 years

First QC Date

April 8, 2013

Last Update Submit

September 28, 2016

Conditions

Patients Awaiting a Living Kidney Donation

Keywords

bortezomibdesensitizationliving kidney transplantation

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with Donor specific antibody (DSA) level below 1000MFI authorizing the living kidney donation

    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 Outcomes (8)

  • Absolute and relative differences of the DSA titer ans antiHLA non DSA titer 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 clinical symptoms and anomalies

    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

    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

    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

    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

  • +3 more secondary outcomes

Study Arms (1)

Bortezomib

EXPERIMENTAL

Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation

Drug: Bortezomib

Interventions

BortezomibDRUG

Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation

Bortezomib

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital

Le Kremlin-Bicêtre, 94 275, France

RECRUITING

MeSH Terms

Interventions

Bortezomib

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hélène François, MD, PhD

    Assistance Publique Hôpitaux de Paris - Bicêtre Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hélène François, MD, PhD

CONTACT

33(0)145212722helene.francois@bct.aphp.fr

Antoine DURRBACH, MD, PhD

CONTACT

33(0)145212771antoine.durrbach@bct.aphp.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2013

First Posted

April 29, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2017

Study Completion

March 1, 2018

Last Updated

September 29, 2016

Record last verified: 2016-09

Locations

FR(1)