Transplant Antibody-Mediated Rejection: Guiding Effective Treatments

Sponsor
Imperial College London
Study ID
NCT03994783
Phase
PHASE3
Status
Terminated

Conditions

  • Antibody-mediated Rejection
  • Kidney Transplant Rejection

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    2 intravenous infusions of rituximab or approved biosimilar given 14 days +/- 2 days apart.
  • Methylprednisolone — DRUG
    Intravenous infusion of methylprednisolone
  • Intravenous Immunoglobulin — DRUG
    High dose (2 g/kg total) or Low dose (100 mg/kg, n=7)
  • Plasma Exchange — PROCEDURE
    Blood is removed from the patient and filtered to remove the plasma. Red and white blood cells and platelets are returned to the patient with replacement fluid.

Study Details

This trial evaluates the addition of rituximab to standard of care in the treatment of antibody-mediated rejection in kidney transplant patients. The trial will involve adults and children. Half of participants will receive standard of care (methylprednisolone, intravenous immunoglobulin and plasma exchange), while the other half will receive standard of care and rituximab.

Key Dates

Start date
Jul 17, 2019
Status verified
Apr 2025
Primary completion
Jul 17, 2021
Completion
Jan 9, 2023

Study Design

Enrollment
3 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care (SOC)
    Intravenous Methylprednisolone (500 mg (600 mg/m2 for paediatric participants), n=3) Plasma Exchange (PEX) (60 ml/kg max 4 l (1 - 1.5 plasma volumes for paediatric participants), n=7) Intravenous Immunoglobulin (high dose: 2 g/kg total, or low dose: 100 mg/kg n=7 after each PEX, no dose adjustment for paediatric participants)
  • Experimental: Standard of Care plus Rituximab (SOCR)
    Intravenous Methylprednisolone (500 mg (600 mg/m2 for paediatric participants), n=3) Plasma Exchange (PEX) (60 ml/kg max 4 l (1 - 1.5 plasma volumes for paediatric participants), n=7) Intravenous Immunoglobulin (high dose: 2 g/kg total, or low dose: 100 mg/kg n=7 after each PEX, no dose adjustment for paediatric participants) Rituximab (375 mg/m2 max 1 g (no dose adjustment for paediatric participants), n=2 14 days +/- 2 days apart)

Primary Outcome Measure

Allograft Survival as assessed by statistical model [ Time Frame: 4 years ]

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