TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients

Sponsor
Vastra Gotaland Region
Study ID
NCT04561986
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Antibody-mediated Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Tocilizumab is a recombinant humanized monoclonal antibody directed against the human interleukin-6 (IL-6) receptor

Study Details

This multi-center study is an investigator-driven randomized controlled parallel group open-label clinical trial designed to evaluate the efficacy of addition of anti-IL-6 antibody tocilizumab (TCZ) to the standard of care (SOC) treatment as compared to the SOC alone in reducing the decline of graft function in kidney transplant recipients with late or chronic antibody-mediated rejection (AMR). A total of 50 recipients will be allocated to receive either TCZ (n=25) added to the standard of care (SOC) or SOC alone (n=25) for a period of 24 months. Patients will be followed for an additional 12 months. Protocol kidney graft biopsies will be performed at 12 and 24 months. The primary outcome is the mean rate of change in graft function as assessed by estimated glomerular filtration rate (eGFR) slope from baseline to 24 months after start of treatment.

Key Dates

First listed
Sep 24, 2020
Start date
Feb 1, 2022
Status verified
Aug 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: Standard of care (SOC) + tocilizumab (TCZ)
    SOC, as below + TCZ (162 mg every week, subcuataneous administration)
  • No Intervention: Arm B: SOC
    Tacrolimus (target concentration 6 ±1 µg/L) + MPA (1.5-2 g/day as tolerated) + prednisolone (not less than 5 mg/day), all oral administration

Primary Outcome Measure

Change from baseline in eGFR at 24 months [ Time Frame: Baseline and 24 months ]

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