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

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.

Timeline

Start

2025-11-01

Primary completion

2027-03-01

Completion

2027-09-30

Drugs

Indications