Daratumumab for Late Antibody-Mediated Rejection

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Martin

About this trial

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.

Eligibility criteria

Qualifiers

Kidney transplant recipient (first or subsequent transplant)

Diagnosis of late ABMR (diagnosed >12 months post-transplant)

Biopsy-proven ABMR

Presence of de novo DSA

Disqualifiers

Active infection

Other significant comorbidities that could affect outcomes or treatment safety

Contraindications to daratumumab

Prior treatment with daratumumab

Trial design

Treatments tested in this trial

  • Daratumumab (Subcutaneously)
  • control group

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators