Comparison Between Bortezomib and Rituximab Plus Plasmapheresis in AMR
- Registration Number
- NCT03737136
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- All patients presented with renal biopsy demonstrating ABMR in the absence of T-cell-mediated rejection
- Mixed AMR and T cell rejection
- do not sign the consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Plasmapheresis plus Bortezomib Bortezomib 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
- Primary Outcome Measures
Name Time Method graft survival at month 6 following diagnosis Glomerular Filtration Rate
- Secondary Outcome Measures
Name Time Method Renal functional tests at month 6 following diagnosis Serum Cr
Changes in Grading of antibody mediated rejection regarding Banff criteria in pathology at month 6 following diagnosis kidney biopsy
DSAs-MFI at month 6 following diagnosis Serum Test
Trial Locations
- Locations (1)
SBMU
🇮🇷Tehran, Iran, Islamic Republic of