Desensitization With Bortezomib Before a Living Kidney Donation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Desensitization With Bortezomib Before a Living Kidney Donation

Conditions
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Patients Awaiting a Living Kidney Donation

Intervention / Treatment
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* Drug: Bortezomib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bortezomib<br>Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation | Drug: Bortezomib<br>* Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation<br>|

What is the study measuring?
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bortezomib, desensitization, living kidney transplantation