Actively Recruiting
Daratumumab for Late Antibody-Mediated Rejection
Led by University Hospital, Martin · Updated on 2025-07-23
20
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Daratumumab for Late Antibody-Mediated Rejection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University hospital Martin
Martin, Slovakia, 03601
Actively Recruiting
Research Team
I
Ivana Dedinska, prof, MD, PhD., MHA, FERA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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