Daratumumab for Late Antibody-Mediated Rejection in Kidney Transplant Recipients With De Novo Donor-Specific Antibodies: A Case-Control Study

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Kidney transplant recipient (first or subsequent transplant)

• Diagnosis of late ABMR (diagnosed \>12 months post-transplant)

• Biopsy-proven ABMR

• Presence of de novo DSA

Locations
Other Locations
Slovakia
University hospital Martin
RECRUITING
Martin
Contact Information
Primary
Ivana Dedinska, prof, MD, PhD., MHA, FERA
ivana.dedinska@uniba.sk
+421 904 386 220
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Active_comparator: Dara
Kidney transplant recipients with late ABMR and de novo DSA treated with daratumumab (1800mg subcutaneous, weekly x 4, then monthly x 6).
Other: control group
Kidney transplant recipients with late ABMR and de novo DSA treated with standard therapies (IVIG, plasmapheresis, rituximab, etc.) prior to the start of the daratumumab study.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Martin

This content was sourced from clinicaltrials.gov