A Phase 4 interventional study of Bortezomib in Patients Awaiting a Living Kidney Donation, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-09-29.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Treatment
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.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
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
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
Time frame: up 6 months after bortezomib treatment and before transplantation
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
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
Frequency of clinical symptoms and anomalies
Safety and efficacy of 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
Frequency of side effects
Safety and efficacy of 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
Frequency of anomalies at the standard blood tests
Safety and efficacy of 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
Frequency of anomalies at the total lymphocyte count and phenotyping
Safety and efficacy of 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
Frequency of proteinuria and anomalies at the glomerular filtration rate
Safety and efficacy of 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
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
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
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
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
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Assistance Publique - Hôpitaux de Paris