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

Conditions

• Microvascular Inflammation - MVI in Kindey Transplant Recipients

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• DARATUMUMAB (DARZALEX®) — DRUG
  Daratumumab 1800 mg subcutaneously once monthly × 3 doses plus standard monitoring of DSA and dd-cfDNA every 3 months.
• 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.

Study Details

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.

Key Dates

Start date

Nov 1, 2025

Status verified

Nov 2025

Primary completion

Mar 1, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental: Daratumumab (Darzalex®)
  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).
• Active Comparator: Active Comparator: Observation (Standard Care)
  Participants with biopsy-proven MVI, C4d-negative, randomized to observation under standard post-transplant care and monitoring (DSA, dd-cfDNA, eGFR) without daratumumab treatment.

Primary Outcome Measure

Primary Outcome: Change in microvascular inflammation score (Banff g + ptc) between baseline and 12 months. [ Time Frame: Baseline (study entry) and 12 months after randomization ]