RecruitingNCT04334707

Kidney Precision Medicine Project


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

1,000 participants

Start Date

Sep 1, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

Acute kidney injury (AKI) and chronic kidney disease (CKD) impose a significant global health burden. Yet, no effective therapies currently exist for AKI, and only a few are available for CKD. Despite significant effort from industry and academia, development of pharmacologic therapies for AKI and CKD has been hampered by: Non-predictive animal models The inability to identify and prioritize human targets The limited availability of human kidney biopsy tissue A poor understanding of AKI and CKD heterogeneity Historically, AKI and CKD have been described as single, uniform diseases. However, growing consensus suggests that different disease pathways lead to different subgroups of AKI and CKD (AKIs and CKDs). Access to human kidney biopsy tissue is a critical first step to define disease heterogeneity and determine the precise molecular pathways that will facilitate identification of specific drug targets and ultimately enable individualized care for people with AKI and CKD. A number of research centers across the United States are collaborating to bring state-of-the-art technologies together to: * Ethically obtain and evaluate kidney biopsies from participants with AKI or CKD * Define disease subgroups * Create a kidney tissue atlas * Identify critical cells, pathways, and targets for novel therapies The KPMP is made up of three distinct, but highly interactive, activity groups: * Recruitment Sites: The recruitment sites (RS) are responsible for recruiting participants with AKI or CKD into the longitudinal study and performing the kidney biopsy. * Tissue Interrogation Sites: The tissue interrogation sites (TIS) are responsible for developing and using innovative technologies to analyze the biopsy tissue. * Central Hub: The central hub is responsible for aggregating, analyzing, and visualizing the generated data and providing scientific, infrastructure, and administrative support for the KPMP consortium.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting kidney biopsy samples and detailed health data from people with chronic kidney disease (CKD) caused by diabetes or high blood pressure, as well as from healthy volunteers. The goal is to identify precise biological markers that explain why kidney disease progresses differently in different people, in order to develop better, personalized treatments. **You may be eligible if...** - You have diabetes (type 1 or 2) with evidence of persistent kidney damage - OR you have high blood pressure with evidence of kidney damage - Your kidney function and protein levels in urine fall within the study's specific ranges - You are otherwise willing and able to undergo a kidney biopsy **You may NOT be eligible if...** - You have rapidly changing kidney function due to an acute illness - Your kidney disease is caused by a condition other than diabetes or hypertension - You have conditions that make a kidney biopsy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREKidney Biopsy

A kidney biopsy is a procedure that involves taking a small piece of kidney tissue for examination with a microscope. A licensed health care provider will perform a kidney biopsy.

OTHERMRI

Images will be acquired using 3.0T whole body scanner. The participant will undergo a series of sequences (e.g., BOLD, diffusion-weighted, ASL MRI, native T1, and fat fraction sequences). The participant will receive 20 mg of IV furosemide as a bolus. BOLD MRI sequences will be repeated 15 minutes after furosemide administration. ASL sequences are acquired using investigational protocols that are not FDA-approved. Siemens machines will use Body ASL PCASL Perfusion WIP 1023, Phillips will use Body ASL 2D PCASL Perfusion software, and GE machines will use Body ASL PCASL Perfusion software.

OTHERRetina Scan

Fundus photography, fluorescein angiography, optical coherence tomography, optical coherence tomography angiography, and ophthalmologic exam and history will take place during one retina study visit. The retina visit will take place up to 6 weeks prior to the KPMP kidney biopsy OR up to 8 weeks post-biopsy.


Locations(13)

University of Arizona

Tucson, Arizona, United States

Yale University

New Haven, Connecticut, United States

University of Illinois Chicago

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic, Rochester

Rochester, Minnesota, United States

Mount Sinai

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Texas at Southwestern

Dallas, Texas, United States

University of Washington

Seattle, Washington, United States

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NCT04334707


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