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Chronic-active antibody-mediated rejection (cAMR) due to de novo or pre-formed donor specific antibody (DSA) is currently considered the main cause of long-term allograft losses.Based on the aim of reducing or eliminating DSA, some proposed different therapeutic regimens for cAMR treatment. All of these protocols were derived from previous experience using acute antibody-mediated rejection and desensitization protocols, and mainly consisted of steroids, plasma exchange (PE), IVIG and RTX in various modalities. More recently, bortezomib was also proposed.To evaluate the role of a therapeutic regimen with plasma exchange, intravenous immunoglobulins and rituximab with or without Bortezomib in chronic-active antibody-mediated rejection (cAMR) settings this study designed.
20 kidney transplant recipients (KTRs) with a diagnosis of cAMR in a prospective randomized clinical trial will be recruited in two arms
: ten KTRs treated with plasmapheresis, intravenous immunoglobulins and rituximab (PE-IVIG-RTX group) vs 10 patients receiving the same therapy plus Bortezomib. Differences between transplanted kidney survival and functional outcomes 6 mo after diagnosis and histological features and donor-specific antibody (DSA) characteristics (MFI ) will be investigated between two arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasmapheresis | No Intervention | 5 Sessions Plasmapheresis and 100 mg/kg Intra venous immunoglobulin at the end of each session and one dose 375mg/m2 rituximab at the end of last session | |
| Plasmapheresis plus Bortezomib | Active Comparator | Drug 5 Sessions Plasmapheresis and 100 mg/kg Intra venous immunoglobulin at the end of each session and one dose 375ml/m2 rituximab at the end of last session plus bortezomib Injections 1.3mg/m2 intravenously on days 1, 4, 8, and 11 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | one cycle of bortezomib (each cycle: 1.3mg/m2 intravenously on days 1, 4, 8, and 11) |
|
| Measure | Description | Time Frame |
|---|---|---|
| graft survival | Glomerular Filtration Rate | at month 6 following diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Renal functional tests | Serum Cr | at month 6 following diagnosis |
| Changes in Grading of antibody mediated rejection regarding Banff criteria in pathology | kidney biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shahid Beheshti MU sbmu | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SBMU | Tehran | Iran |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| at month 6 following diagnosis |
| DSAs-MFI | Serum Test | at month 6 following diagnosis |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |