RecruitingNot Applicable

Daratumumab for Late Antibody-Mediated Rejection

Slovakia20 participantsStarted 2025-07-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Is daratumumab superior to standard therapies (IVIG, plasmapheresis, rituximab) in improving outcomes in kidney transplant recipients with late antibody-mediated rejection (ABMR) and de novo donor-specific antibodies (DSA)?

Timeframe: 7 months

Trial details

NCT IDNCT07081126

SponsorUniversity Hospital, Martin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-31

Contact for this trial

Ivana Dedinska, prof, MD, PhD., MHA, FERA

+421 904 386 220 ivana.dedinska@uniba.sk

View on ClinicalTrials.gov More Kidney Tansplant trials