About the Kidney Precision Medicine Project

Background

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.

Community feedback indicates that—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.

Goals of the KPMP

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

Create a kidney tissue atlas

Define disease subgroups

Identify critical cells, pathways, and targets for novel therapies

How We’re Organized

The KPMP is made up of three distinct, but highly interactive, activity groups:

Recruitment Sites

The recruitment sites 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 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.

Path to the Kidney Tissue Atlas

PARTICIPANT Recruitment
  • Biopsies
  • Biospecimens
  • Clinical phenotypes
Central Biorepository
  • Tissue & slides
  • Blood, urine, stool
Tissue Interrogation
  • Transcriptomics
  • Proteomics
  • Metabolomics
  • Imaging
Data Integration
  • Store
  • Standardize
  • Validate
Kidney Tissue Atlas
  • Analyze
  • Visualize
  • Share
PARTICIPANT Recruitment
  • Biopsies
  • Biospecimens
  • Clinical phenotypes
Central Biorepository
  • Tissue & slides
  • Blood, urine, stool
Tissue Interrogation
  • Transcriptomics
  • Proteomics
  • Metabolomics
  • Imaging
Data Integration
  • Store
  • Standardize
  • Validate
Kidney Tissue Atlas
  • Analyze
  • Visualize
  • Share

Creating the Atlas begins with recruiting participants with either chronic kidney disease or acute kidney injury to take part in the study. Consented participants undergo a kidney biopsy procedure, donate blood, urine and stool biospecimens, and answer a variety of questionnaires. 

All biospecimens are sent to the KPMP Central Biorepository. The Biorepository sends the specimens to various tissue interrogation sites, where it undergoes further analysis.

The data which is generated from these analyses is returned to the KPMP Central Hub, where it is stored, standardized across sites, further analyzed, and then used to create new visualizations of the kidney. The data and visualizations are combined to create the Kidney Tissue Atlas.

 

Proposed 10-year Timeline

2017 - 2019

  • Optimize and validate tissue processing and interrogation methods
  • Establish common clinical protocols and cohort studies enrolling a small number of AKI or CKD participants
  • Assess quality of phenotype data and biopsy protocols at each site
  • Begin work on kidney tissue atlas
  • Optimize next generation assays

2019 - 2022

  • Small scale proof of concept studies to determine robustness of clinical and analytic pipelines
  • Implement next generation tissue interrogation assays
  • Enrich the kidney tissue atlas
  • Expand longitudinal cohort studies in initial AKI or CKD populations

2022 - 2027

  • Expand to larger cohort studies

Patient Advocacy

Patients are at the heart of what we do and why we do it.

One of the unique aspects of the KPMP is our commitment to involving patients in every facet of the project. Our patient advocates are active participants in working groups, face-to-face meetings, and ad hoc teams, tackling issues such as community engagement, biopsy safety, ethics, and data sharing strategies. They bring their unique perspectives to every discussion and provide vital project input during patient panels at each face-to-face meeting.

Want to become an advocate?

By becoming a patient advocate in the KPMP, you will have an opportunity to help improve and transform the diagnosis and treatment of kidney disease for future patients just like you. For more information, read our patient advocacy primer.

Governance

To provide a community resource for advancing research in this area, all KPMP activities must meet rigorous sharing and quality control standards. Given the risk of complications from a biopsy, the KPMP will hold ethical and participant safety considerations paramount. The KPMP will work closely with participants to ensure that their viewpoints, priorities, and preferences inform all aspects of the project.

All of the KPMP activities will be overseen by a Data and Safety Monitoring Board (DSMB) constituted by the NIDDK that will focus on participant safety, study burden, and scientific validity of the clinical data; and an External Expert Panel (EEP) constituted by the NIDDK that will focus on the overall scientific progress and direction of the KPMP.

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