Daratumumab for late antibody-mediated rejection in kidney transplant recipients with new donor-specific antibodies
Daratumumab for Late Antibody-Mediated Rejection in Kidney Transplant Recipients With De Novo Donor-Specific Antibodies: A Case-Control Study
This research tests whether daratumumab can help kidney transplant recipients who develop late antibody-mediated rejection after forming new donor-specific antibodies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Martin Academic / other |
| Drugs / interventions | daratumumab, rituximab |
| Locations | 1 site (Martin) |
| Trial ID | NCT07081126 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Martin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.