Comparison Between Bortezomib and Rituximab Plus Plasmapheresis in AMR
NCT ID: NCT03737136
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2019-11-01
2025-09-01
Brief Summary
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Detailed Description
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: 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Plasmapheresis
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
No interventions assigned to this group
Plasmapheresis plus 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
Bortezomib
one cycle of bortezomib (each cycle: 1.3mg/m2 intravenously on days 1, 4, 8, and 11)
Interventions
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Bortezomib
one cycle of bortezomib (each cycle: 1.3mg/m2 intravenously on days 1, 4, 8, and 11)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* do not sign the consent
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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nooshin dalili
Principal Investigator
Principal Investigators
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Shahid Beheshti MU sbmu
Role: PRINCIPAL_INVESTIGATOR
Shahid Beheshti University of Medical Sciences
Locations
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SBMU
Tehran, , Iran
Countries
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Other Identifiers
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SMBU11254/B
Identifier Type: -
Identifier Source: org_study_id
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