Daratumumab for Late Antibody-Mediated Rejection

Sponsor
University Hospital, Martin
Study ID
NCT07081126
Status
Recruiting
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Conditions

  • Acute Rejection (AR) of Transplanted Kidney
  • Kidney Tansplant

Eligibility Criteria

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

Interventions

  • Daratumumab (Subcutaneously) — DRUG
    Kidney transplant recipients with late ABMR and de novo DSA treated with daratumumab (1800mg subcutaneous, weekly x 4, then monthly x 6).
  • control group — OTHER
    Kidney transplant recipients with late ABMR and de novo DSA treated with standard therapies (IVIG, plasmapheresis, rituximab, etc.) prior to the start of the daratumumab study.

Study Details

The study titled "Daratumumab for Late Antibody-Mediated Rejection in Kidney Transplant Recipients with De Novo Donor-Specific Antibodies" (DARTABMR) is a case-control investigation assessing whether daratumumab is more effective than standard therapies (such as IVIG, plasmapheresis, and rituximab) in treating late antibody-mediated rejection (ABMR) in kidney transplant patients with new donor-specific antibodies (DSA). The research compares outcomes like kidney function stabilization, DSA reduction, and biopsy improvements between patients receiving daratumumab and those on standard treatments. Participants include transplant recipients diagnosed with ABMR more than 12 months post-transplant, with data collected on clinical, immunological, and biopsy parameters before, during, and after treatment. The study emphasizes matching participants based on key variables to minimize bias and will analyze treatment success rates, changes in kidney function and DSA levels, and adverse events.

Key Dates

Start date
Jul 1, 2025
Status verified
Jul 2025
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dara
    Kidney transplant recipients with late ABMR and de novo DSA treated with daratumumab (1800mg subcutaneous, weekly x 4, then monthly x 6).
  • Other: control group
    Kidney transplant recipients with late ABMR and de novo DSA treated with standard therapies (IVIG, plasmapheresis, rituximab, etc.) prior to the start of the daratumumab study.

Primary Outcome Measure

Is daratumumab superior to standard therapies (IVIG, plasmapheresis, rituximab) in improving outcomes in kidney transplant recipients with late antibody-mediated rejection (ABMR) and de novo donor-specific antibodies (DSA)? [ Time Frame: 7 months ]

Central Contacts

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