Kidney TansplantDARTABMRNCT07081126
Daratumumab for Late Antibody-Mediated Rejection
A study testing Daratumumab (Subcutaneously) in people with Kidney Tansplant and Acute Rejection (AR) of Transplanted Kidney, run by University Hospital, Martin at 1 site in Slovakia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Tansplant, Acute Rejection (AR) of Transplanted Kidney
- What is being tested?
- Daratumumab (Subcutaneously)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney transplant recipient (first or subsequent transplant)
- Diagnosis of late ABMR (diagnosed >12 months post-transplant)
- Biopsy-proven ABMR
- Presence of de novo DSA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site, 1 recruiting
- Recruiting
University hospital Martin
Martin, 03601
About this study
Official title: Daratumumab for Late Antibody-Mediated Rejection in Kidney Transplant Recipients With De Novo Donor-Specific Antibodies: A Case-Control Study
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.
Read the detailed description
The DARTABMR study is a comprehensive case-control research project designed to evaluate the efficacy of daratumumab in treating late antibody-mediated rejection (ABMR) in kidney transplant recipients with de novo donor-specific antibodies (DSA). The primary objective is to determine whether daratumumab offers superior outcomes compared to standard therapies like intravenous immunoglobulin (IVIG), plasmapheresis, and rituximab.
Study Design and Population:
This is a retrospective and prospective case-control study involving kidney transplant recipients diagnosed with late ABMR, defined as occurring more than 12 months post-transplant. Patients are divided into two groups: the case group receiving daratumumab (1800 mg subcutaneously, weekly for four doses, then monthly for six doses) and a control group previously treated with standard therapies. Inclusion criteria encompass first or subsequent kidney transplants with biopsy-proven ABMR and presence of de novo DSA. Exclusion criteria include active infections, significant comorbidities, prior daratumumab treatment, contraindications, and non-adherence to immunosuppression protocols. Patients are matched based on ABMR diagnosis timing, baseline kidney function, DSA characteristics, number of transplants, age, and ethnicity to minimize confounding.
Intervention and Data Collection:
All participants, both cases and controls, are maintained on a standardized immunosuppressive regimen consisting of tacrolimus, mycophenolate mofetil (MMF), and steroids, with specified targets and documentation of any deviations. Data collected encompass demographic information, clinical history, immunosuppressive details, kidney function tests (creatinine, eGFR), DSA levels (via Luminex), and biopsy findings using Banff scoring and molecular analyses. For the daratumumab group, assessments occur at baseline, during treatment, and after the last dose, including monitoring for infections, adverse events, and immune profiles via flow cytometry and cell-free DNA (cfDNA). For controls, retrospective data on treatment regimens, kidney function, DSA levels, biopsy results, infections, and safety are gathered.
Outcome Measures and Analysis:
The primary endpoint is treatment success, defined by improvement or stabilization of kidney function, significant reduction in DSA levels (e.g., ≥50% MFI decrease), and favorable biopsy changes. Graft survival during follow-up is also considered. Secondary analyses compare changes in kidney function, DSA levels, biopsy scores, and incidence of adverse events between groups. Statistical methods include chi-square or Fisher's exact tests for success rates, t-tests or ANOVA for continuous variables, and regression analyses to control for residual confounders.
Summary:
Overall, the DARTABMR aims to provide evidence on whether daratumumab can improve outcomes in late ABMR cases with de novo DSA, potentially influencing future treatment protocols for this challenging clinical scenario.
- Being tested
- Daratumumab (Subcutaneously), control group
- Keywords
- daratumumab, kidney transplant, acute antibody mediated rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daratumumab (Subcutaneously)Drug
Kidney transplant recipients with late ABMR and de novo DSA treated with daratumumab (1800mg subcutaneous, weekly x 4, then monthly x 6).
control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dara | Active comparator | Kidney transplant recipients with late ABMR and de novo DSA treated with daratumumab (1800mg subcutaneous, weekly x 4, then monthly x 6). Receives: Drug: Daratumumab (Subcutaneously) |
| control group | Other | 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. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Jul 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TansplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Vnucak, University Hospital, Martin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081126
- Sponsor's protocol ID
- TNO_UNM_DARA
- Acronym
- DARTABMR
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daratumumab for Late Antibody-Mediated Rejection in Kidney Transplant Recipients With De Novo Donor-Specific Antibodies: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07081126
- Acronym / sponsor ID
- DARTABMR / TNO_UNM_DARA
- Keywords
- daratumumab, kidney transplant, acute antibody mediated rejection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, MartinUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The DARTABMR study is a comprehensive case-control research project designed to evaluate the efficacy of daratumumab in treating late antibody-mediated rejection (ABMR) in kidney transplant recipients with de novo donor-specific antibodies (DSA). The primary objective is to determine whether daratumumab offers superior outcomes compared to standard therapies like intravenous immunoglobulin (IVIG), plasmapheresis, and rituximab.
Study Design and Population:
This is a retrospective and prospective case-control study involving kidney transplant recipients diagnosed with late ABMR, defined as occurring more than 12 months post-transplant. Patients are divided into two groups: the case group receiving daratumumab (1800 mg subcutaneously, weekly for four doses, then monthly for six doses) and a control group previously treated with standard therapies. Inclusion criteria encompass first or subsequent kidney transplants with biopsy-proven ABMR and presence of de novo DSA. Exclusion criteria include active infections, significant comorbidities, prior daratumumab treatment, contraindications, and non-adherence to immunosuppression protocols. Patients are matched based on ABMR diagnosis timing, baseline kidney function, DSA characteristics, number of transplants, age, and ethnicity to minimize confounding.
Intervention and Data Collection:
All participants, both cases and controls, are maintained on a standardized immunosuppressive regimen consisting of tacrolimus, mycophenolate mofetil (MMF), and steroids, with specified targets and documentation of any deviations. Data collected encompass demographic information, clinical history, immunosuppressive details, kidney function tests (creatinine, eGFR), DSA levels (via Luminex), and biopsy findings using Banff scoring and molecular analyses. For the daratumumab group, assessments occur at baseline, during treatment, and after the last dose, including monitoring for infections, adverse events, and immune profiles via flow cytometry and cell-free DNA (cfDNA). For controls, retrospective data on treatment regimens, kidney function, DSA levels, biopsy results, infections, and safety are gathered.
Outcome Measures and Analysis:
The primary endpoint is treatment success, defined by improvement or stabilization of kidney function, significant reduction in DSA levels (e.g., ≥50% MFI decrease), and favorable biopsy changes. Graft survival during follow-up is also considered. Secondary analyses compare changes in kidney function, DSA levels, biopsy scores, and incidence of adverse events between groups. Statistical methods include chi-square or Fisher's exact tests for success rates, t-tests or ANOVA for continuous variables, and regression analyses to control for residual confounders.
Summary:
Overall, the DARTABMR aims to provide evidence on whether daratumumab can improve outcomes in late ABMR cases with de novo DSA, potentially influencing future treatment protocols for this challenging clinical scenario.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dara | Active comparator | Drug: Daratumumab (Subcutaneously)Kidney transplant recipients with late ABMR and de novo DSA treated with daratumumab (1800mg subcutaneous, weekly x 4, then monthly x 6). |
| control group | Other | Other: control groupKidney 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Kidney transplant recipient (first or subsequent transplant)
- Diagnosis of late ABMR (diagnosed >12 months post-transplant)
- Biopsy-proven ABMR
- Presence of de novo DSA
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daratumumab (Subcutaneously)Kidney transplant recipients with late ABMR and de novo DSA treated with daratumumab (1800mg subcutaneous, weekly x 4, then monthly x 6). | Drug | Dara |
| control groupKidney 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. | Other | control group |
Primary outcome
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)?
Time frame: 7 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Tansplant
RecruitingObservational study
Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients
Hemodyalysis, Kidney Tansplant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daratumumab (Subcutaneously) in people with Kidney Tansplant and Acute Rejection (AR) of Transplanted Kidney, run by University Hospital, Martin at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivana Dedinska, prof, MD, PhD., MHA, FERA (+421 904 386 220, ivana.dedinska@uniba.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)? (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.