deltatrials
Completed OBSERVATIONAL NCT05384899

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

Central Hub for Kidney Precision Medicine

Sponsor: Beth Israel Deaconess Medical Center

Updated 6 times since 2022 Last updated: Apr 20, 2026 Started: Jun 15, 2021 Primary completion: Jun 30, 2022 Completion: Oct 30, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Acute Kidney Failure and Acute Kidney Insufficiency, this trial is completed. The trial is conducted by Beth Israel Deaconess Medical Center and has accumulated 6 data snapshots since 2021. Infectious disease trials contribute critical data for public health response and treatment development.

Study Description(click to expand)

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...

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.

Status Flow

~Jun 2022 – ~Jun 2024 · 24 months · monthly snapshotActive Not Recruiting~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshotUnknown~Feb 2025 – ~Apr 2026 · 15 months · monthly snapshotUnknownApr 28, 2026 – present · 11 days · daily APICompleted

Change History

6 versions recorded
  1. Apr 28, 2026 — Present [daily]

    Completed

    Status: UnknownCompleted

  2. Feb 2025 — Apr 2026 [monthly]

    Unknown

  3. Sep 2024 — Feb 2025 [monthly]

    Unknown

  4. Jul 2024 — Sep 2024 [monthly]

    Unknown

    Status: Unknown StatusUnknown

  5. Jun 2024 — Jul 2024 [monthly]

    Unknown Status

    Status: Active Not RecruitingUnknown Status

Show 1 earlier version
  1. Jun 2022 — Jun 2024 [monthly]

    Active Not Recruiting

    First recorded

Jun 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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.

Contact Information

Sponsor contact:
  • Beth Israel Deaconess Medical Center
  • Broad Institute of MIT and Harvard
  • Icahn School of Medicine at Mount Sinai
  • Indiana University
  • Johns Hopkins University
  • Joslin Diabetes Center
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Ohio State University
  • Pacific Northwest National Laboratory
  • Princeton University
  • Stanford University
  • The University of Texas Health Science Center at San Antonio
  • University of California, San Diego
  • University of California, San Francisco
  • University of Michigan
  • University of Texas
  • University of Washington
  • Washington University School of Medicine
  • Yale University
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .