Active — Not RecruitingPhase 4

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

Slovakia20 participantsStarted 2025-11-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Baseline (study entry) and 12 months after randomization

Trial details

NCT IDNCT07274462

SponsorUniversity Hospital, Martin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-01

View on ClinicalTrials.gov More Microvascular Inflammation - MVI in Kindey Transplant Recipients trials