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New treatment option for Kidney Tansplant
Official title Daratumumab for Late Antibody-Mediated Rejection
ClinicalTrials.gov ID: NCT07081126
What this study is testing
What is Daratumumab (Subcutaneously)?
Daratumumab (Subcutaneously) is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for kidney tansplant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Kidney transplant recipient (first or subsequent transplant)
- Diagnosis of late ABMR (diagnosed \>12 months post-transplant)
- Biopsy-proven ABMR
- Presence of de novo DSA
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Martin, Slovakia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Martin, Slovakia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.