Desensitization With Bortezomib Before a Living Kidney Donation
- Registration Number
- NCT01842074
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- 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
- positive cell dependent cytotoxicity CM,
- DSA level above 3000 MFI
- and every condition that is a contre indication for bortezomib treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bortezomib Bortezomib Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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 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
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 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
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
Trial Locations
- Locations (1)
Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital
🇫🇷Le KREMLIN-BICETRE, France