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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001988-78 | EudraCT Number |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bortezomib | Experimental | Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hélène François, MD, PhD | Contact | 33(0)145212722 | helene.francois@bct.aphp.fr | |
| Antoine DURRBACH, MD, PhD | Contact | 33(0)145212771 | antoine.durrbach@bct.aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Hélène François, MD, PhD | Assistance Publique Hôpitaux de Paris - Bicêtre Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital | Recruiting | Le Kremlin-Bicêtre | 94 275 | France |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| 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 |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |