This study has been completed.
Urine CXCL10 Monitoring Trial in Kidney Transplant
About This Study
This Phase II-III multi-center randomized controlled trial evaluates whether urinary CXCL10 monitoring to detect and treat early subclinical rejection improves outcomes in adult renal transplant recipients. Patients with confirmed elevations in urinary CXCL10 between 2 weeks and 9 months post-transplant are randomized 1:1 to either an intervention arm or a standard-of-care control arm. The intervention group undergoes a renal biopsy for elevated CXCL10 levels, with biopsy-proven rejection treated per protocol, while the control group receives routine surveillance based on serum creatinine and proteinuria. All randomized participants undergo a protocol biopsy at 12 months to assess primary and long-term allograft outcomes.
Who Can Participate?
✓ Inclusion Criteria
- •Participants must be able to understand and provide written informed consent
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •All ethnic and gender groups will have equal access to the study
- •Incident adult (age ≥18) renal transplant patients with a living or deceased donor kidney transplant
- •Confirmed elevated urine CXCL10: Cr without a urinary tract infection or gross hematuria.
✗ Exclusion Criteria
- •Primary non-function
- •Blood group (ABO) incompatible
- •Pre-transplant donor specific antibody (DSA) positive (MFI>1000 OR positive flow crossmatch)
- •Human leukocyte (HLA) 0 HLA antigen D-related (DR) + 0 major HLA class 2 (DQ) mismatch
- •Presence of other transplanted organ or co-transplanted organ
- •Medical contraindication to biopsy or rejection treatment
- •Followed outside of investigational center
- •Participation in other interventional trials within 4-weeks post-transplant or anytime post-transplant till study end at 12-months
- •Intention to not use a maintenance immunosuppression regimen consisting of calcineurin inhibitor (CNI) and anti-proliferative agents
- •Any condition that, in the opinion of the investigator, would pose risk to the subject's safe participation, or interfere with their ability to comply with the study requirements, or may impact the quality of interpretation of the data.