Kidney Precision Medicine Project

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.

Conditions

• Acute Kidney Failure
• Acute Kidney Insufficiency
• Acute Renal Failure
• Acute Renal Injury
• Acute Renal Insufficiency
• Kidney Failure, Acute
• Kidney Insufficiency, Acute
• Renal Failure, Acute
• Renal Insufficiency, Acute
• Chronic Kidney Diseases
• Chronic Kidney Insufficiency
• Chronic Renal Diseases
• Chronic Renal Insufficiency
• Kidney Insufficiency, Chronic
• Type 1 Diabetes (T1D)

Interventions

PROCEDURE

Kidney 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.

OTHER

MRI

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.

OTHER

Retina 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Washington

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Broad Institute of MIT and Harvard

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Indiana University

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Joslin Diabetes Center

  collaborator OTHER

• Pacific Northwest National Laboratory

  collaborator FED

• Princeton University

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• The University of Texas Health Science Center at San Antonio

  collaborator OTHER

• University of Texas

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Yale University

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• Providence Health & Services

  collaborator OTHER

• Harvard University

  collaborator OTHER

• University of Arizona

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  lead OTHER

Principal Investigators

• Jonathan Himmelfarb, MD · Icahn School of Medicine at Mount Sinai

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-01

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• United States

Study Locations