Renal Allograft FibrosisNCT05058170
Renal Allograft Fibrosis Study
An observational study of Renal Allograft Fibrosis, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Allograft Fibrosis
- How many people
- 162 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Feb 2022to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosed renal allograft fibrosis.
Who may be able to join
- Patients post renal transplantation, with acute or chronic allograft dysfunction, referred for biopsy based on clinical grounds (indication biopsy). Patients with be considered to have allograft dysfunction if: 1. Patients will be considered to have acute allograft dysfunction if there is a 15% decline in eGFR or a 0.3-mg/dL increase in sCr level, with laboratory and clinical findings that exclude pre-renal or post-renal dysfunction. 2. Patients will be considered to have chronic allograft dysfunction if there is a sustained >50% increase in sCr/decrease in eGFR (over their post-transplant nadir creatinine), occurring over a period of >3 months, with laboratory and clinical findings that exclude pre-renal or post-renal dysfunction.
- Patients with stable allograft function and donor-specific antibody (DSA) positivity, referred for surveillance biopsy at 3 and 12 months post transplantation. Patients with be considered to have stable allograft function if: 1. Patients will be considered to have chronic stable allograft function if they have a stable eGFR > 45 ml/min \& a spot urine protein:creatinine ratio < 0.2; 2. Stable creatinine/eGFR (i.e. <25% change in serum creatinine (Cr) and/or eGFR from post transplant baseline).
- Patient is able to give informed consent for this study.
- Study team will recruit patients after 1 month post-transplant period since the early post transplant course is associated with increased risk of acute dysfunction (i.e. acute tubular necrosis or acute rejection episodes).
- Healthy volunteers with no renal disease will be recruited for protocol optimization and to serve as controls.
- Potential renal donors undergoing clinical non-contrast or contrast-enhanced MRI will be recruited to serve as controls.
Who cannot join
- Age less than 18 years.
- Renal transplantation <1 month prior to scanning.
- Evidence of large vessel or urinary tract complication of the renal transplant.
- Unable or unwilling to give informed consent.
- Contra-indications to MRI
- Electrical implants such as cardiac pacemakers or perfusion pumps.
Show all 13Show fewer
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants.
- Ferromagnetic objects such as jewelry or metal clips in clothing.
- Pregnant subjects.
- Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions.
- The inclusion and exclusion criteria are identical at ISMMS and WCMC.
- Screening for eligibility will be performed by the transplant nephrology team at both centers. Data relevant to eligibility will be reviewed, including age, presence of allograft dysfunction and its ascertainment (clinical, laboratory and prior biopsy data), and MRI safety will also be reviewed by the study coordinator.
- There are no exclusions based on race, sex/gender, preferred language.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Weill Cornell Medicine
New York, New York, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Characterization of Renal Allograft Fibrosis and Prediction of Outcome Using a Quantitative MRI Approach
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.
- Conditions
- Renal Allograft Fibrosis
- Keywords
- Renal allograft fibrosis, Kidney, Chronic Kidney Disease, Transplant, MRI
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Renal transplant patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of renal allograft fibrosis
Detection of the presence of renal allograft fibrosis using MRI in patients undergoing biopsies.
Measured: 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).
Measured: 2 weeks after renal allograft biopsy
Secondary outcomes (7)
Presence of renal allograft inflammation
Detection of the presence of renal allograft inflammation using MRI in patients undergoing biopsies.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Within 2 years after initial MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start4 Feb 2022
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Allograft FibrosisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Sara Lewis, Icahn School of Medicine at Mount Sinai
- Investigators
- Sara Lewis, MD, Principal investigator, Icahn School of Medicine at Mount SinaiOctavia Bane, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058170
- Sponsor's protocol ID
- GCO 20-2690
- Other IDs
- R01DK129888
- Status last verified
- Jun 2025
- First submitted
- 16 Sep 2021
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not encompassed in the grant proposal to share data with others outside of this study.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Renal Allograft Fibrosis and Prediction of Outcome Using a Quantitative MRI Approach
- ClinicalTrials.gov ID
- NCT05058170
- Acronym / sponsor ID
- GCO 20-2690
- Conditions
- Renal Allograft Fibrosis
- Keywords
- Renal allograft fibrosis, Kidney, Chronic Kidney Disease, Transplant, MRI
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal transplant patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed renal allograft fibrosis.
Key inclusion criteria (6 listed)
- Patients post renal transplantation, with acute or chronic allograft dysfunction, referred for biopsy based on clinical grounds (indication biopsy). Patients with be considered to have allograft dysfunction if: 1. Patients will be considered to have acute allograft dysfunction if there is a 15% decline in eGFR or a 0.3-mg/dL increase in sCr level, with laboratory and clinical findings that exclude pre-renal or post-renal dysfunction. 2. Patients will be considered to have chronic allograft dysfunction if there is a sustained >50% increase in sCr/decrease in eGFR (over their post-transplant nadir creatinine), occurring over a period of >3 months, with laboratory and clinical findings that exclude pre-renal or post-renal dysfunction.
- Patients with stable allograft function and donor-specific antibody (DSA) positivity, referred for surveillance biopsy at 3 and 12 months post transplantation. Patients with be considered to have stable allograft function if: 1. Patients will be considered to have chronic stable allograft function if they have a stable eGFR > 45 ml/min \& a spot urine protein:creatinine ratio < 0.2; 2. Stable creatinine/eGFR (i.e. <25% change in serum creatinine (Cr) and/or eGFR from post transplant baseline).
- Patient is able to give informed consent for this study.
- Study team will recruit patients after 1 month post-transplant period since the early post transplant course is associated with increased risk of acute dysfunction (i.e. acute tubular necrosis or acute rejection episodes).
- Healthy volunteers with no renal disease will be recruited for protocol optimization and to serve as controls.
Key exclusion criteria (13 listed)
- Age less than 18 years.
- Renal transplantation <1 month prior to scanning.
- Evidence of large vessel or urinary tract complication of the renal transplant.
- Unable or unwilling to give informed consent.
- Contra-indications to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of renal allograft fibrosis
Time frame: 2 weeks after renal allograft biopsy
Detection of the presence of renal allograft fibrosis using MRI in patients undergoing biopsies.
Banff scoring system for fibrosis
Time frame: 2 weeks after renal allograft biopsy
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).
7 secondary outcomes
Presence of renal allograft inflammation
Time frame: 2 weeks after renal allograft biopsy
Banff scoring system for inflammation
Time frame: 2 weeks after renal allograft biopsy
4-gene fibrosis signature score
Time frame: Within 1 year of urine processing
3-gene inflammation score
Time frame: Within 1 year of urine processing
Change in estimated Glomerular filtration rate (eGFR)
Time frame: Baseline and within 2 years after initial MRI
Change in Protein level in urine
Time frame: Baseline and within 2 years after initial MRI
Change in Interstitial fibrosis and tubular atrophy (IFTA) stage
Time frame: Within 2 years after initial MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No. Not encompassed in the grant proposal to share data with others outside of this study.
Related trials for Renal Allograft Fibrosis
RecruitingObservational study
Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients
Acute Rejection (AR) of Transplanted Kidney, Chronic Allograft Nephropathy (CAN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Lewis, MD principal investigator
Icahn School of Medicine at Mount Sinai
Octavia Bane, PhD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Allograft Fibrosis, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of renal allograft fibrosis (time frame: 2 weeks after renal allograft biopsy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.