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NCT05058170

Renal Allograft Fibrosis Study

Enrolling by Invitation
Not specifiedAges 18+Observational
Icahn School of Medicine at Mount Sinai
~162 participants
Updated 2025-07-01 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Presence of renal allograft fibrosis
Measured over 2 weeks after renal allograft biopsy
+1 more outcome measured

Conditions

Renal Allograft Fibrosis

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NCT05058170

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Icahn School of Medicine at Mount Sinai

    New York, New Yorkno site contact published

  • Weill Cornell Medicine

    New York, New Yorkno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sara Lewis, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Octavia Bane, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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

What this trial measures

  • Presence of renal allograft fibrosis2 weeks after renal allograft biopsy

    Detection of the presence of renal allograft fibrosis using MRI in patients undergoing biopsies.

  • Banff scoring system for fibrosis2 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).