A Randomized Controlled Study of Daratumumab for Microvascular Inflammation (MVI) in Kidney Transplant Recipients With or Without Donor-Specific Antibodies
Phase: PHASE4
Conditions: Microvascular Inflammation - MVI in Kindey Transplant Recipients
Sponsor: University Hospital, Martin

UNIVERZITNÁ  NEMOCNICA  MARTIN 
 
KOLLÁROVA  2,  036 59 MARTIN  
Transplantačno-nefrologické oddelenie 
Transplant-nephrology department 
  
tc@unm.sk 
+ 421 43 4203 184 
 
 
 
 
 
STUDY TITLE 
A Randomized Controlled Study of Daratumumab for 
Microvascular 
Inflammation 
(MVI) 
in 
Kidney 
Transplant Recipients With or Without Donor-Specific 
Antibodies 
 
(DARA-MVI) 
 
 
 
 
 
 
 
 
 
 
 
NCT number:  

UNIVERZITNÁ  NEMOCNICA  MARTIN 
 
KOLLÁROVA  2,  036 59 MARTIN  
Transplantačno-nefrologické oddelenie 
Transplant-nephrology department 
  
tc@unm.sk 
+ 421 43 4203 184 
 
 
In Martin, Slovakia     05th NOV 2025 
Acronym 
DARA-MVI 
Study 
(Daratumumab 
for 
Microvascular 
Inflammation 
in 
Kidney 
Transplantation) 
Official Title 
A Randomized Controlled Study of Daratumumab for Microvascular Inflammation (MVI) in 
Kidney Transplant Recipients With or Without Donor-Specific Antibodies 
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. 
Study Design 
Type: Interventional (Clinical Trial) 
Allocation: Randomized (1:1 ratio) 
Intervention Model: Parallel Assignment 
Masking: Open-label (pathology and laboratory assessments blinded) 
Primary Purpose: Treatment 
Estimated Enrollment: 80 participants (40 per cohort) 
Randomization: Block randomization (block size = 4) using MedCalc software 
Duration: 12-month follow-up per participant 
 
 

UNIVERZITNÁ  NEMOCNICA  MARTIN 
 
KOLLÁROVA  2,  036 59 MARTIN  
Transplantačno-nefrologické oddelenie 
Transplant-nephrology department 
  
tc@unm.sk 
+ 421 43 4203 184 
 
Arms and Interventions 
Arm A – Observation: Participants with MVI, C4d-negative, and DSA-negative will undergo 
observation with standard monitoring. DSA and dd-cfDNA will be measured every 3 
months for 12 months. 
Arm B – Daratumumab: Daratumumab 1800 mg subcutaneously once monthly × 3 doses 
plus standard monitoring of DSA and dd-cfDNA every 3 months. 
Control Group: Biopsy-negative, DSA-negative, dd-cfDNA-negative patients matched for 
time post-transplant and donor type. 
Outcome Measures 
Primary Outcome: Change in microvascular inflammation score (Banff g + ptc) between 
baseline and 12 months. 
Secondary Outcomes: 
1. Change in eGFR from baseline to 12 months. 
2. Development of de novo DSA. 
3. Change in dd-cfDNA (% and copies/mL). 
4. Histologic resolution/progression of MVI. 
5. Adverse events related to daratumumab. 
6. Patient and graft survival at 12 months. 
Eligibility Criteria 
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. 
 
 

UNIVERZITNÁ  NEMOCNICA  MARTIN 
 
KOLLÁROVA  2,  036 59 MARTIN  
Transplantačno-nefrologické oddelenie 
Transplant-nephrology department 
  
tc@unm.sk 
+ 421 43 4203 184 
 
Timeline 
Start: March 2026 | Primary completion: March 2027 | Study completion: September 2027 
Locations 
University Hospital Martin, Slovakia  
Principal Investigator 
Ivana Dedinská, MD, PhD – Transplant Nephrology Unit 
Keywords 
Kidney transplantation, MVI, daratumumab, dd-cfDNA, DSA, plasma cell therapy, C4d-
negative rejection