Phase
Condition
Scar Tissue
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients post renal transplantation, with acute or chronic allograft dysfunction,referred for biopsy based on clinical grounds (indication biopsy). Patients with beconsidered to have allograft dysfunction if: 1. Patients will be considered to haveacute allograft dysfunction if there is a 15% decline in eGFR or a 0.3-mg/dLincrease in sCr level, with laboratory and clinical findings that exclude pre-renalor post-renal dysfunction. 2. Patients will be considered to have chronic allograftdysfunction if there is a sustained >50% increase in sCr/decrease in eGFR (overtheir post-transplant nadir creatinine), occurring over a period of >3 months, withlaboratory 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 posttransplantation. Patients with be considered to have stable allograft function if:
- Patients will be considered to have chronic stable allograft function if theyhave 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 frompost transplant baseline).
Patient is able to give informed consent for this study.
Study team will recruit patients after 1 month post-transplant period since theearly 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 optimizationand to serve as controls.
Potential renal donors undergoing clinical non-contrast or contrast-enhanced MRIwill be recruited to serve as controls.
Exclusion
Exclusion Criteria:
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.
Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses,artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoosnear 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 seizuresor claustrophobic reactions.
The inclusion and exclusion criteria are identical at ISMMS and WCMC.
Screening for eligibility will be performed by the transplant nephrology team atboth centers. Data relevant to eligibility will be reviewed, including age, presenceof allograft dysfunction and its ascertainment (clinical, laboratory and priorbiopsy data), and MRI safety will also be reviewed by the study coordinator.
There are no exclusions based on race, sex/gender, preferred language.
Study Design
Connect with a study center
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Weill Cornell Medicine
New York, New York 10021
United StatesSite Not Available
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