A Phase 2 interventional study of Bortezomib and Plasma exchanges and intravenous immunoglobulins in Chronic Antibody-mediated Transplant Rejection, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
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
Chronic active antibody-mediated rejection (AMR) is considered as a main cause of late allograft losses in kidney transplant recipients. It is due to the occurrence of de novo donor-specific anti-HLA antibodies (DSA), i.e. antibodies synthetized by the recipient after transplantation against its transplant. There is currently to efficient treatment. The purpose of our study is to determine the efficacy of bortezomib, a proteasome inhibitor, in the treatment of chronic active antibody-mediated rejection, in association with steroids, plasma exchanges, and polyclonal intravenous immunoglobulins. Patients are recipients of a first or a second kidney transplant for more than 3 months. They display de novo DSA i.e. DSA not detected the day of transplantation and in pre-transplant sera.. They display signs of chronic active AMR on kidney biopsy i.e. a glomerulitis (g) + peritubular capillaritis (ptc) Banff score g+ptc ≥ 2, with or without severe chronic glomerulopathy (Banff score cg\<3). Kidney biopsy may have been performed systematically or because of: :
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Inclusion Criteria:
Given the teratogenic risks described in the SPCs of Velcade and Cellcept:
Exclusion Criteria:
Five plasma exchanges, two cycles of bortezomib + dexamethasone, 4 courses of polyclonal intravenous immunoglobulins
Drug: Bortezomib
Five plasma exchanges, dexamethasone, 4 courses of polyclonal intravenous immunoglobulins
Drug: Plasma exchanges and intravenous immunoglobulins
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)
Also known as: Velcade
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)
histological lesions of humoral rejection and immunodominant donor specific antibody
Between inclusion biopsy and end of study biopsy delta g+ptc ≤1 and delta cg \< 1 (Banff score of glomerulitis (g) capillaritis (ptc) and chronic allograft glomerulopathy (cg) Between inclusion and end of study, decrease in mean fluorescence intensity (MFI) of the immunodominant donor specific anti-HLA antibody (DSA with the highest MFI) by Luminex greater than 50%
Time frame: one year
histological lesions of humoral rejection
Between inclusion biopsy and end of study biopsy delta g+ptc ≤1 and delta cg \< 1 (Banff score of glomerulitis (g) capillaritis (ptc) and chronic allograft glomerulopathy (cg)
Time frame: one year
immunodominant donor specific antibody
Between inclusion and end of study, decrease in mean fluorescence intensity (MFI) of the immunodominant donor specific anti-HLA antibody (DSA with the highest MFI) by Luminex greater than 50%
Time frame: one year
all donor specific antibodies at one year
Between inclusion and end of study, variation of the title of each DSA and the sum of the DSAs
Time frame: one year
all donor specific antibodies
Between inclusion and month-6, evolution in mean fluorescence intensity (MFI) of all donor specific anti-HLA antibodies by Luminex
Time frame: 6 months
Histological lesions
Description of all histological lesions observed at one-year biopsy according to the Banff classification and comparison with inclusion biopsy: acute cellular rejection, interstitial fibrosis and tubular atrophy, chronic vascular lesions (arteriolar hyalinosis, fibro-intimal thickening), chronic rejection (transplant glomerulopathy, fibroproliferative endarteritis)
Time frame: one year
renal function and proteinuria
Evolution between inclusion and end of study at one-year of serum creatinine, estimated GFR (MDRD formula), proteinuria output, proteinuria/creatinuria ratio
Time frame: one year
Safety of bortezomib in renal transplant recipients
Infectious and non-infectious adverse events occurring during study in the two arms of treatment
Time frame: one year
Patient and graft survival
Time frame: one year
T and B lymphocytes subsets with bortezomib
Flow cytometry study of T and B lymphocytes subsets at inclusion, month-6 and month-12 in patients treated with bortezomib
Time frame: one year
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris