Kidney Precision Medicine Project

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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 criteria

Qualifiers

Use of glucose-lowering therapy (insulin or oral or other subcutaneous agents)

International Classification of Diseases (ICD) 9/10 diagnostic code for diabetes

Estimated glomerular filtration rate 30-59 mL/min/1.73m2 or

Estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73m2 with urine albumin excretion greater than or equal to 30 mg/g creatinine (or mg/day) or

Disqualifiers

Under 18 years of age

Severe allergy to iodinated contrast

Pregnancy

Transplant recipient (includes solid transplant and bone marrow)

Trial design

Treatments tested in this trial

  • Kidney Biopsy
  • MRI
  • Retina Scan

Treatment groups

1,000 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Icahn School of Medicine at Mount Sinai

Lead sponsor

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

Collaborator

University of Washington

Collaborator

University of Michigan

Collaborator

Brigham and Women's Hospital

Collaborator

Broad Institute of MIT and Harvard

Collaborator

The Cleveland Clinic

Collaborator

Columbia University

Collaborator

Indiana University

Collaborator

Johns Hopkins University

Collaborator

Joslin Diabetes Center

Collaborator

Pacific Northwest National Laboratory

Collaborator

Princeton University

Collaborator

Ohio State University

Collaborator

University of Pittsburgh

Collaborator

The University of Texas Health Science Center at San Antonio

Collaborator

University of Texas

Collaborator

Washington University School of Medicine

Collaborator

Yale University

Collaborator

Mayo Clinic

Collaborator

University of North Carolina, Chapel Hill

Collaborator

University of Illinois at Chicago

Collaborator

Vanderbilt University

Collaborator

Providence Health & Services

Collaborator

Harvard University

Collaborator

University of Arizona

Collaborator