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Daratumumab for Late Antibody-Mediated Rejection

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Martin
NCT07081126 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 wil

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📋 Eligibility rules (as published)
Inclusion Criteria: * Kidney transplant recipient (first or subsequent transplant) * Diagnosis of late ABMR (diagnosed \>12 months post-transplant) * Biopsy-proven ABMR * Presence of de novo DSA Exclusion Criteria: * Active infection * Other significant comorbidities that could affect outcomes or treatment safety * Contraindications to daratumumab * Prior treatment with daratumumab * Specific types of DSA (consider specifying, e.g., unacceptable antigens) * Non-adherence to standardized immunosuppression protocol (tacrolimus, MMF, steroids) * iFTA 2 or 3 on baseline biopsy
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What it tests

  • Daratumumab (Subcutaneously)
  • control group
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Where

1 site
University hospital Martin
Martin, Slovakia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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