IVIG/Rituximab vs Rituximab in Kidney Transplant With de Novo Donor-specific Antibodies

Sponsor
Seoul National University Hospital
Study ID
NCT04033276
Phase
PHASE4
Status
Completed

Conditions

  • Renal Transplant

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    IV rituximab
  • intravenous immune globulin — DRUG
    iv intravenous immune globulin

Study Details

The objective of this study was to compare two strategies of de novo donor specific antibodies (DSA) and antibody-mediated rejection (AMR) prevention in renal transplant recipients: high dose intravenous immunoglobulin (IVIG)/rituximab regimens versus rituximab alone.

Key Dates

Start date
Jan 8, 2019
Status verified
May 2022
Primary completion
Dec 31, 2021
Completion
May 3, 2022

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Rituximab
    Inj Rituximab 375mg/m2 IV given on day 0
  • Active Comparator: Combination of high-dose IVIG and Rituximab
    IV Rituximab 375mg/m2 on day 0 and IV high-dose IVIG 2g/kg on day 0

Primary Outcome Measure

change in delta DSA MFI sum [ Time Frame: baseline and 3 months post-treatment, 1 year post-treatment ]

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