Bortezomib in Rejection of Kidney Transplants

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 11, 2015

Primary Completion Date

July 16, 2020

Study Completion Date

July 16, 2020

Conditions
Chronic Antibody-mediated Transplant Rejection
Interventions
DRUG

Bortezomib

"1. Five plasma exchanges +0.1 g/kg of intravenous immunoglobulins at the end of each course~2. two cycles of bortezomib (1.3 mg/m2 IV at day-1, day-4, day-8, day-11) + oral dexamethasone (20 mg po at day-1, day-4, day-8, day-11)~3. four courses of polyclonal intravenous immunoglobulins every three weeks (2g/kg, the first two courses are performed simultaneously with the two bortezomib cycles)"

DRUG

Plasma exchanges and intravenous immunoglobulins

"1. Five plasma exchanges +0.1 g/kg of intravenous immunoglobulins at the end of each course~2. four courses of polyclonal intravenous immunoglobulins every three weeks (2g/kg)~3. oral dexamethasone (20 mg po at day-1, day-3, day-5, day-7 of the two first intravenous immunoglobulins courses)"

Trial Locations (1)

75015

Hopital Necker Enfants-malades, Paris

All Listed Sponsors
collaborator

Fondation Centaure

OTHER

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT02201576 - Bortezomib in Rejection of Kidney Transplants | Biotech Hunter | Biotech Hunter