Clinical trial NCT01842074: Desensitization With Bortezomib Before a Living Kidney Donation
Official title: Desensitization With Bortezomib Before a Living Kidney Donation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Patients Awaiting a Living Kidney Donation
Keywords: bortezomib
desensitization
living kidney transplantation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-04-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with Donor specific antibody (DSA) level below 1000MFI authorizing the living kidney donation
timeFrame: up 6 months after bortezomib treatment and before transplantation
Secondary outcomes:
measure: Absolute and relative differences of the DSA titer ans antiHLA non DSA titer bortezomib treatment
timeFrame: 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
measure: Frequency of clinical symptoms and anomalies
timeFrame: 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
measure: Frequency of side effects
timeFrame: 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
measure: Frequency of anomalies at the standard blood tests
timeFrame: 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
measure: Frequency of anomalies at the total lymphocyte count and phenotyping
timeFrame: 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
measure: Frequency of proteinuria and anomalies at the glomerular filtration rate
timeFrame: 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
measure: Proportion of transplanted patients
timeFrame: 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
measure: Incidence of biopsy proven acute rejection and chronic rejection
timeFrame: 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
Other outcomes:
Locations:
city: Le KREMLIN-BICETRE
country: France
facility: Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital
Study officials:
affiliation: Assistance Publique Hôpitaux de Paris - Bicêtre Hospital
name: Hélène François, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: