Kidney Precision Medicine Project (KPMP) - COVID-19 Protocol

Covid19 Clinical Trial

Official title: Central Hub for Kidney Precision Medicine

Status Active, not recruiting

Clinical Trial Summary

Since its inception, KPMP has developed sophisticated protocols for collection and analysis of human kidney tissue, and for collection of biofluids. Members of the consortium have wide-ranging expertise in conducting clinical studies, processing kidney tissue, advanced structural and molecular analysis and complex bioinformatics analysis, which will be used to leverage effectively as a group to better understand kidney disease.

This joint protocol aims to synergize the COVID-19 study efforts of KPMP academic research centers, to collectively study COVID-19, including its renal presentation using kidney tissue and/or biofluids from patients suffering from COVID-19. This will increase the breadth and depth of data available to the public to expedite discoveries, identify therapeutics, and improve outcomes for patients with COVID-19. It will additionally bring the expertise of KPMP investigators to bear against this pandemic.

Clinical Trial Description

The COVID-19 pandemic has drastically altered life globally and killed thousands since its emergence in December of 2019. Unfortunately, the global toll will only continue to increase. Sars-CoV-2, the virus responsible for COVID-19, may directly infect kidney cells, with currently known clinical manifestations of Acute Kidney Injury or nephrotic range proteinuria. Individuals with chronic kidney disease (CKD), diabetes and hypertension are at increased risk of severe COVID-19 infections.

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.

Since its inception, KPMP has developed sophisticated protocols for collection and analysis of human kidney tissue, and for collection of biofluids. Members of the consortium have wide-ranging expertise in conducting clinical studies, processing kidney tissue, advanced structural and molecular analysis and complex bioinformatics analysis, which will be used to to leverage effectively as a group to better understand kidney disease.

This joint protocol aims to synergize the COVID-19 study efforts of KPMP academic research centers, to collectively study COVID-19, including its renal presentation using kidney tissue and/or biofluids from patients suffering from COVID-19. This will increase the breadth and depth of data available to the public to expedite discoveries, identify therapeutics, and improve outcomes for patients with COVID-19. It will additionally bring the expertise of KPMP investigators to bear against this pandemic. ;

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Acute Kidney Insufficiency
• Acute Renal Failure
• Acute Renal Injury
• Acute Renal Insufficiency
• COVID-19
• Covid19
• Kidney Failure, Acute
• Kidney Insufficiency, Acute
• Renal Failure, Acute
• Renal Insufficiency
• Renal Insufficiency, Acute
• Sars-CoV-2 Infection

• NCT number: NCT05384899
• Study type: Observational
• Source: University of Washington
• Status: Active, not recruiting
• Start date: June 15, 2021
• Completion date: October 30, 2022