DARA-MVI Study (Daratumumab for Microvascular Inflammation in Kidney Transplantation)

NCT07274462 | Active Not Recruiting Phase 4

• 1 other identifier: TNO DARA MVI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The DARA-MVI Study is a prospective, randomized, controlled, open-label trial designed to evaluate the effect of daratumumab on microvascular inflammation (MVI) in kidney transplant recipients with C4d-negative biopsies. Participants with biopsy-proven MVI will be randomized to receive either daratumumab or observation with standard monitoring. The study will assess changes in histologic MVI score, donor-derived cell-free DNA (dd-cfDNA), donor-specific antibodies (DSA), and graft function over 12 months.

Conditions

Microvascular Inflammation - MVI in Kindey Transplant Recipients

Keywords

Kidney transplantation; Microvascular inflammation; acute rejection

Outcome Measures

Primary Outcomes (1)

• Primary Outcome: Change in microvascular inflammation score (Banff g + ptc) between baseline and 12 months.

  The composite microvascular inflammation (MVI) score, defined as the sum of glomerulitis (g) and peritubular capillaritis (ptc) scores according to the Banff classification (range 0-6), will be assessed on kidney-allograft biopsy specimens obtained at baseline and at 12 months. The change in total MVI score (ΔMVI = \[g + ptc\]₁₂ₘ - \[g + ptc\]₀) will be compared between treatment arms to evaluate the effect of daratumumab on microvascular inflammation.

  Baseline (study entry) and 12 months after randomization

Study Arms (2)

Experimental: Daratumumab (Darzalex®)

EXPERIMENTAL

Participants with biopsy-proven microvascular inflammation (MVI) (Banff g ≥1 and/or ptc ≥1), C4d-negative, randomized to receive daratumumab 1800 mg SC once monthly for 3 months, in addition to standard post-transplant care and monitoring (DSA, dd-cfDNA, eGFR).

Drug: DARATUMUMAB (DARZALEX®)

Active Comparator: Observation (Standard Care)

ACTIVE COMPARATOR

Participants with biopsy-proven MVI, C4d-negative, randomized to observation under standard post-transplant care and monitoring (DSA, dd-cfDNA, eGFR) without daratumumab treatment.

Other: Observation (Standard Care)

Interventions

Observation (Standard Care) OTHER

Standard post-transplant management and monitoring per institutional protocol. Includes serial measurement of DSA and donor-derived cell-free DNA every 3 months, eGFR monitoring, and repeat biopsy at 12 months.

Also known as: Active Comparator: Observation (Standard Care)

Active Comparator: Observation (Standard Care)

DARATUMUMAB (DARZALEX®) DRUG

Daratumumab 1800 mg subcutaneously once monthly × 3 doses plus standard monitoring of DSA and dd-cfDNA every 3 months.

Also known as: Experimental: Daratumumab (Darzalex®)

Experimental: Daratumumab (Darzalex®)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18, kidney transplant recipients (first or higher, living or deceased donor), biopsy-proven MVI (g ≥ 1 and/or ptc ≥ 1), C4d-negative, DSA-negative (Cohort 1) or DSA-positive (Cohort 2), informed consent.

You may not qualify if:

• C4d-positive biopsy, active TCMR ≥ IA, infection or malignancy, multi-organ transplant, prior anti-CD38 therapy, pregnancy, breastfeeding.

Sponsors & Collaborators

• University Hospital, Martin: lead

Study Sites (1)

Transplant-nephrology department

Martin, 036 01, Slovakia

Location

MeSH Terms

Interventions

daratumumab; Observation; Standard of Care

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label (pathology and laboratory assessments blinded)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: from 01/MAR/2025 for 20 years

Locations

SL (1)