Daratumumab for late antibody-mediated rejection in kidney transplant recipients with new donor-specific antibodies
Official title: Daratumumab for Late Antibody-Mediated Rejection in Kidney Transplant Recipients With De Novo Donor-Specific Antibodies: A Case-Control Study
Run by University Hospital, Martin · NCT07081126 · Data updated 2026-11-12
This research tests whether daratumumab can help kidney transplant recipients who develop late antibody-mediated rejection after forming new donor-specific antibodies.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University Hospital, Martin Academic / other |
| Drugs / interventions | daratumumab, rituximab |
| Locations | 1 site (Martin) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | July 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 23, 2025 |
| Trial ID | NCT07081126 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are kidney transplant recipients diagnosed with biopsy-proven late ABMR (>12 months post-transplant) who have de novo donor-specific antibodies and no active infection or major contraindications to daratumumab.
✕Probably not a fit
Patients with early ABMR (<12 months), advanced chronic scarring on biopsy (iFTA grade 2–3), active infections, or prior daratumumab exposure are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a case-control study combining retrospective and prospective data that compares patients treated with subcutaneous daratumumab to matched controls treated with standard therapies such as IVIG, plasmapheresis, and rituximab. Daratumumab is given as 1800 mg subcutaneously weekly for four doses then monthly for six doses, with all patients maintained on a standardized tacrolimus/mycophenolate/steroid regimen. Participants are matched on timing of ABMR, baseline kidney function, DSA characteristics, transplant number, age, and ethnicity to reduce bias. Outcomes include kidney function trajectories, changes in DSA levels, biopsy findings, treatment success rates, and adverse events.
Why it matters
Potential benefit: If successful, daratumumab could better lower harmful donor-specific antibodies and help stabilize kidney function, potentially reducing the risk of graft loss.
How similar studies have gone: Daratumumab has shown benefit in hematologic diseases and there are only small case series and reports suggesting potential benefit for ABMR, so the approach is novel with limited controlled evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University hospital Martin
Martin, Slovakia Recruiting
Study contacts
- Study coordinator: Ivana Dedinska, prof, MD, PhD., MHA, FERA
- Email: ivana.dedinska@uniba.sk
- Phone: +421 904 386 220
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.