RecruitingNot ApplicableNCT07081126

Daratumumab for Late Antibody-Mediated Rejection

Daratumumab for Late Antibody-Mediated Rejection in Kidney Transplant Recipients With De Novo Donor-Specific Antibodies: A Case-Control Study


Sponsor

University Hospital, Martin

Enrollment

20 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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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Interventions

DRUGDaratumumab (Subcutaneously)

Kidney transplant recipients with late ABMR and de novo DSA treated with daratumumab (1800mg subcutaneous, weekly x 4, then monthly x 6).

OTHERcontrol 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.


Locations(1)

University hospital Martin

Martin, Slovakia

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NCT07081126


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