Urinary biomarkers and cells in kidney transplant patients
Research type
Research Study
Full title
A pilot/feasibility study to evaluate the utility of urinary cells and biomarkers for the assessment of transplant pathology and kidney function.
IRAS ID
352265
Contact name
Mysore Keshavmurthy Phanish
Contact email
Sponsor organisation
Epsom and St Helier University Hospitals NHS trust, St Georges University Hospitals NHS trust (GESH)
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Pathology in transplanted kidneys predominantly involves tubulo-interstitial compartment. Acute and chronic transplant rejections are associated with interstitial inflammation, tubulitis and varying degrees of scarring. In this work we will investigate if cells shed in the urine and urinary biomarkers reflect intrarenal pathology and inflammatory milieu.
Transplant kidney biopsy, an invasive procedure is the current gold-standard for the diagnosis of renal allograft pathology. Urinary biomarkers that reflect glomerular damage, tubule cell damage and inflammation along with analysis of cells shed in the urine could provide valuable information that reflects intra-renal pathology (what is happening inside the kidney). We have previously derived (and published in KI reports) a panel of urinary biomarkers that are of value in identifying progressors in diabetic kidney disease (ACR, RBP, MCP1). This work also identified NAG as marker of early kidney damage. Part 1 of the study: We will test these biomarkers in kidney transplant patients coming into our renal unit for a clinically indicated transplant kidney biopsy (urine collected pre biopsy).
Part 2 of the study will involve studying cells shed in the urine (tubular epithelial calls and inflammatory cells). Before undergoing biopsy, patients will collect urine in a novel device in which cells are captured on a membrane,
replacing centrifugation with filtration technology. The technology has been validated by our collaborator at the Encelo laboratories demonstrating increased efficiency for isolation of tubule epithelial cells shed in urine. From RNA extracted from these cells we will do RT-PCR for inflammatory cytokines (MCP1 and IL6), BK virus and EDA fibronectin.
Part 3:
At least 20mL of freshly collected urine in a universal container will be processed for flow cytometry to identify and characterise urinary inflammatory cell population at the Royal Free Hospital, utilising published protocols from our collaborator.REC name
Wales REC 5
REC reference
25/WA/0264
Date of REC Opinion
19 Sep 2025
REC opinion
Favourable Opinion