Patients Awaiting a Living Kidney Donation
Conditions
Keywords
bortezomib, desensitization, living kidney transplantation
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.
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.
Interventions
DRUGBortezomib
Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with Donor specific antibody (DSA) level below 1000MFI authorizing the living kidney donation | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Safety and efficacy of bortezomib treatment |
| 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 | Safety and efficacy of bortezomib treatment |
| 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 | Safety and efficacy of bortezomib treatment |
| 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 | Safety and efficacy of bortezomib treatment 12 months after transplantation if performed, if not 6 month after the last bortezomib injection |
| Frequency of proteinuria and anomalies at the glomerular filtration rate | 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 |
| Proportion of transplanted patients | 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 |
| Incidence of biopsy proven acute rejection and chronic rejection | 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 |
| 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 | Safety and efficacy of bortezomib treatment |
Countries
France
Contacts
Primary ContactHélène François, MD, PhD
Backup ContactAntoine DURRBACH, MD, PhD
Outcome results
None listed