Clincosm LogoSign in Get a demo

Comparison Between Bortezomib and Rituximab Plus Plasmapheresis in AMR

Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT03737136
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
35
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison Between Rituximab + PLX + IVIG With and Without Bortezomib in the Treatment of Antibody Mediated Kidney Transplanted Rejection
Actual Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: 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
Active Comparator: 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

Drug: Bortezomib
one cycle of bortezomib (each cycle: 1.3mg/m2 intravenously on days 1, 4, 8, and 11)
Other Names:
  • Velcade

    		•

    Outcome Measures

    Primary Outcome Measures

    1. graft survival [at month 6 following diagnosis]

      Glomerular Filtration Rate

    Secondary Outcome Measures

    1. Renal functional tests [at month 6 following diagnosis]

      Serum Cr

    2. Changes in Grading of antibody mediated rejection regarding Banff criteria in pathology [at month 6 following diagnosis]

      kidney biopsy

    3. DSAs-MFI [at month 6 following diagnosis]

      Serum Test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients presented with renal biopsy demonstrating ABMR in the absence of T-cell-mediated rejection
    Exclusion Criteria:

    • Mixed AMR and T cell rejection

    • do not sign the consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SBMU Tehran Iran, Islamic Republic of

    Sponsors and Collaborators

    • Shahid Beheshti University of Medical Sciences

    Investigators

    • Principal Investigator: Shahid Beheshti MU sbmu, Shahid Beheshti University of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    nooshin dalili, Principal Investigator, Shahid Beheshti University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT03737136
    Other Study ID Numbers:
    • SMBU11254/B
    First Posted:
    Nov 9, 2018
    Last Update Posted:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by nooshin dalili, Principal Investigator, Shahid Beheshti University of Medical Sciences
    transplantation
    plasmapheresis
    Additional relevant MeSH terms:
    Bortezomib

    Study Results

    No Results Posted as of Jan 28, 2022