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Desensitization With Bortezomib Before a Living Kidney Donation (VELDON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01842074
Recruitment Status : Unknown
Verified September 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : April 29, 2013
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Patients Awaiting a Living Kidney Donation Drug: Bortezomib Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Desensitization With Bortezomib Before a Living Kidney Donation
Study Start Date : March 2013
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bortezomib

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842074


Contacts
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Contact: Hélène François, MD, PhD 33(0)145212722 helene.francois@bct.aphp.fr
Contact: Antoine DURRBACH, MD, PhD 33(0)145212771 antoine.durrbach@bct.aphp.fr

Locations
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France
Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital Recruiting
Le KREMLIN-BICETRE, France, 94 275
Contact: Hélène François, MD, PhD    33(0)145212722    helene.francois@bct.aphp.fr   
Contact: Antoine Durrbach, MD, PhD    33(0)145212771    antoine.durrbach@bct.aphp.fr   
Principal Investigator: Hélène François, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Hélène François, MD, PhD Assistance Publique Hôpitaux de Paris - Bicêtre Hospital
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01842074    
Other Study ID Numbers: P110147
2012-001988-78 ( EudraCT Number )
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Keywords provided by Assistance Publique - Hôpitaux de Paris:
bortezomib
desensitization
living kidney transplantation
Additional relevant MeSH terms:
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Bortezomib
Antineoplastic Agents