Daratumumab for Late Antibody-Mediated Rejection

Recruiting now · Not applicable

Conditions studied: Kidney Tansplant, Acute Rejection (AR) of Transplanted Kidney

In brief

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 facts

Study ID

NCT07081126

Run by

University Hospital, Martin

People needed

20

Starts

2025-07-01

Expected to finish

2026-12-31

Last updated by the study team

2025-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Kidney transplant recipient (first or subsequent transplant)
• Diagnosis of late ABMR (diagnosed >12 months post-transplant)
• Biopsy-proven ABMR
• Presence of de novo DSA

You may not qualify if…

• 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

Where it is running

• University hospital Martin — Martin, Slovakia (enrolling)

Full record on ClinicalTrials.gov

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