Daratumumab for Late Antibody-Mediated Rejection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Martin
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Kidney transplant recipient (first or subsequent transplant)
Diagnosis of late ABMR (diagnosed >12 months post-transplant)
Biopsy-proven ABMR
Presence of de novo DSA
Disqualifiers
Active infection
Other significant comorbidities that could affect outcomes or treatment safety
Contraindications to daratumumab
Prior treatment with daratumumab
Trial design
Design model
Crossover
Treatments tested in this trial
Daratumumab (Subcutaneously)
DrugKidney transplant recipients with late ABMR and de novo DSA treated with daratumumab (1800mg subcutaneous, weekly x 4, then monthly x 6).
control group
Other interventionKidney 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: DaraActive comparator 1 intervention
Group B: control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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)?
The primary outcome measure of the DARTABMR study is the proportion of kidney transplant recipients who achieve treatment success, defined by the following criteria: Improvement or stabilization of kidney function, indicated by no significant decline, or an increase in estimated glomerular filtration rate (eGFR). Reduction in donor-specific antibody (DSA) levels, with a clinically meaningful decrease, such as greater than 50% reduction in mean fluorescence intensity (MFI). Improvement in biopsy findings, evidenced by a reduction in Banff scores for features such as glomerulitis and peritubular capillaritis. The study will compare the percentage of patients meeting these criteria between the daratumumab-treated group and the standard therapy control group during the follow-up period.
Time frame
7 monthsSponsors and contacts
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Source ClinicalTrials.gov