An observational study in Renal Allograft Fibrosis, sponsored by Icahn School of Medicine at Mount Sinai. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Icahn School of Medicine at Mount Sinai · Observational
Despite the reduction in acute rejection episodes in renal transplant patients due to modern immunosuppression, proportionate improvements in long-term allograft survival have not been achieved. Virtually any disease or injury affecting renal allografts can culminate in irreversible injury of tubular epithelial cells and the development of interstitial fibrosis and tubular atrophy (IFTA). Renal allograft fibrosis drives chronic kidney disease (CKD) progression, predicts allograft failure and is associated with increased patient mortality. Other prognostic and/or actionable diagnoses described by the pathologic Banff scheme, such as inflammation, often co-exist and contribute to IFTA. Immune cell infiltration within allografts and within areas of IFTA (i-IFTA) can drive progressive kidney injury, fibrosis and worsened outcome. Pathology is the reference standard for IFTA; however, allograft biopsy has many well-known limitations and is not an ideal method for monitoring patients during trials of new therapies aimed at improving allograft survival. There is an urgent and unmet need for non-invasive assessment of renal allograft IFTA.
Multiparametric MRI (mpMRI), including relaxometry [the spin-lock relaxation time T1ρ, a marker of interaction of water with macromolecules in tissues; the spin-lattice relaxation time T1, a marker of interstitial edema and collagen volume fraction)] and advanced diffusion [intravoxel incoherent motion diffusion-weighted imaging (IVIM-DWI), a marker of diffusion and perfusion] provides insight into renal structure and function. Validation of advanced MRI methods as markers of renal allograft IFTA would be of major clinical significance to enable early detection, assess the efficacy of novel anti-fibrotic agents, and provide longitudinal disease monitoring. The study team has established proof-of-concept in renal allografts with stable function and IFTA without confounding rejection or infection that mpMRI techniques are feasible for measuring fibrosis, especially using the combination of T1 and DWI. The study has established that urinary biomarkers for renal allograft fibrosis are also promising and have been validated against pathology in initial studies.
In this proposal, the researchers will develop a short, non-contrast multiparametric MRI (mpMRI) protocol, consisting of advanced relaxometry (T1 mapping and T1ρ) and advanced diffusion weighted imaging (IVIM-DWI) to accurately detect and stage allograft fibrosis, taking into account confounding Banff variables of inflammation and tested against biopsy. The researchers will also assess the added value of urinary biomarkers of IFTA and if successful, this study will benefit a large population of patients with renal allograft fibrosis in the United States, enabling early diagnosis, optimized treatment planning, prognostication and longitudinal disease monitoring.
3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.
This study's planned enrollment of 162 is below the median of 200 across 867 observational studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
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Patients with diagnosed renal allograft fibrosis.
Exclusion Criteria:
Contra-indications to MRI
The inclusion and exclusion criteria are identical at ISMMS and WCMC.
Presence of renal allograft fibrosis
Detection of the presence of renal allograft fibrosis using MRI in patients undergoing biopsies.
Time frame: 2 weeks after renal allograft biopsy
Banff scoring system for fibrosis
Detection of the severity of renal allograft fibrosis using MRI in patients undergoing biopsies, using the Banff scoring system for interstitial fibrosis (ci) + tubular atrophy (ct); each subscore from 0-3 with full range from 0-6, higher score indicates higher severity).
Time frame: 2 weeks after renal allograft biopsy
Presence of renal allograft inflammation
Detection of the presence of renal allograft inflammation using MRI in patients undergoing biopsies.
Time frame: 2 weeks after renal allograft biopsy
Banff scoring system for inflammation
Detection of the severity of renal allograft inflammation using MRI in patients undergoing biopsies using the Banff scoring system. the Banff lesion scored include inflammation in the area of IFTA (i-IFTA), tubulitis (t), glomerular basement membrane (GBM) double contours (cg), vascular fibrous intimal thickening (cv), glomerulitis (g), intimal arteritis (v), and peritubular capillaritis (ptc), all subscores range, 0-3, with full range 0-3, higher score indicating higher severity.
Time frame: 2 weeks after renal allograft biopsy
4-gene fibrosis signature score
4-gene fibrosis signature score as a measurement of urinary mRNA (which consists of CDH1 mRNA, SLC12A1 mRNA, Vim mRNA and 18S rRNA) obtained from urine cells for the detection of renal allograft fibrosis. Measurement is a continuous scale with no maximum, higher score indicates higher severity.
Time frame: Within 1 year of urine processing
3-gene inflammation score
3-gene inflammation score as a measurement of urinary mRNA (which consists of CD3 mRNA, CXCL10 mRNA, and 18S rRNA) obtained from urine cells for the detection of renal allograft inflammation. Measurement is a continuous scale with no maximum, higher score indicates higher severity.
Time frame: Within 1 year of urine processing
Change in estimated Glomerular filtration rate (eGFR)
Renal function assessed by estimated Glomerular filtration rate (eGFR) which is a test used to check how well the kidneys are working. Specifically, it estimates how much blood passes through the glomeruli each minute. Glomeruli are the tiny filters in the kidneys that filter waste from the blood.
Time frame: Baseline and within 2 years after initial MRI
Change in Protein level in urine
Renal function assessed by protein level in urine to detect proteinuria. Proteinuria is defined as (\>1 g/dL).
Time frame: Baseline and within 2 years after initial MRI
Change in Interstitial fibrosis and tubular atrophy (IFTA) stage
Renal function assessed by change in IFTA stage as determined by the Banff scoring system. The Banff lesion score include interstitial fibrosis (ci) + tubular atrophy (ct). Each subscore range 0-3, with total range from 0-6 and a higher score indicates higher severity.
Time frame: Within 2 years after initial MRI
Plan to share: No — Not encompassed in the grant proposal to share data with others outside of this study.
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Icahn School of Medicine at Mount Sinai