Daratumumab for Late Antibody-Mediated Rejection

NCT07081126 | Recruiting

• 1 other identifier: TNO_UNM_DARA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Tansplant; Acute Rejection (AR) of Transplanted Kidney

Keywords

daratumumab; kidney transplant; acute antibody mediated rejection

Outcome Measures

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.

  7 months

Study Arms (2)

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).

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.

Other: control group

Interventions

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).

Dara

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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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)
• iFTA 2 or 3 on baseline biopsy

Sponsors & Collaborators

• University Hospital, Martin: lead

Study Sites (1)

University hospital Martin

Martin, 03601, Slovakia

RECRUITING

MeSH Terms

Interventions

daratumumab; Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

SL (1)