Desensitization With Bortezomib Before a Living Kidney Donation (VELDON)

Assistance Publique - Hôpitaux de Paris

Status and phase: Unknown; Phase 4

Conditions: Patients Awaiting a Living Kidney Donation

Treatments: Drug: Bortezomib

Study type: Interventional

Funder types: Other

Identifiers

NCT01842074

2012-001988-78 (EudraCT Number)

P110147

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Bortezomib

Experimental group

Description:

Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation

Treatment:

Drug: Bortezomib