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