Bortezomib in Rejection of Kidney Transplants (NCT02201576) | Clinical Trial Compass
CompletedPhase 2
Bortezomib in Rejection of Kidney Transplants
France60 participantsStarted 2015-02-11
Plain-language summary
The purpose of the study is to assess the efficacy of bortezomib, in association with steroids, plasma exchange, and polyclonal intravenous immunoglobulins, in the treatment of chronic antibody mediated rejection due to donor specific anti-HLA antibodies, in kidney transplant recipients
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* recipients of a first or a second kidney transplant for more than 3 months
* age over 18 years
* with de novo donor specific antibodies (DSA), i.e. antibodies not detected the day of transplantation and in pre-transplant sera
* with histological lesions of chronic active antibody-mediated rejection (glomerulitis + peritubular capillaritis banff score and chronic glomerulopathy (g+ptc ≥ 2) on a graft biopsy performed because of renal function deterioration, proteinuria, detection of de novo DSA, or on a systematic biopsy
* written informed consent
* Given the teratogenic risks described in the SPCs of Velcade and Cellcept:
* Women of child bearing age must have a negative pregnancy test the day of the inclusion and should use at least one effective contraceptive method before start of medication during the treatment and during the study
* Men old enough to procreate have to use condoms during the treatment and at least 90 days after the last intake of the treatment during the study. Moreover, given SPCs of Cellcept, it is recommended that female partners to use an effective method of contraception treatment and for 90 days after the last mycophenolate intake by the partner male
* affiliated with social security health insurance
* patients with cell rejection lesions associated with chronic humoral rejection lesions active may be included in the study. This rejection can be treated with 3 boluses of 500 mg of methyl prednisolone prior to inclusion.
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What they're measuring
1
histological lesions of humoral rejection and immunodominant donor specific antibody