Acute Kidney FailureNCT05384899
Kidney Precision Medicine Project (KPMP) - COVID-19 Protocol
An observational study of Acute Kidney Failure and Acute Kidney Insufficiency, run by University of Washington at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure, Acute Kidney Insufficiency, Acute Renal Failure
- How many people
- 90 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Jun 2021to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The KPMP will focus on COVID-19 positive in-hospital populations that account for large proportions of the public health burden of acute and chronic kidney diseases as evidenced by research and federal data.
Who may be able to join
None listed.
Who cannot join
- Any potential participant meeting any one of the general or safety exclusion criteria will not be eligible for enrollment in the KPMP COVID-19 Substudy. Exclusion criteria include non-transient conditions that would not allow for enrollment in the main KPMP study.
- Determined at time of Eligibility Assessment prior to consent:
- Non-English or Spanish language
- Less than 18 years of age
- Severe allergy to iodinated contrast
- Transplant recipient (kidney or non-kidney, including solid organ and bone marrow transplantation)
Show all 15Show fewer
- Additional vulnerable individuals (incarcerated, institutionalized, or otherwise unable to participate in the study)
- Inability to provide informed consent or obtain surrogate consent from a legally authorized representative (LAR)
- Unwilling to receive blood transfusion (if needed)
- Baseline eGFR less than 15 ml/min/m2
- If known at the time of enrollment, or determined by kidney ultrasound before the biopsy procedure (may be the same day as the biopsy procedure)
- Kidney size less than 8 cm (percutaneous biopsies only)
- Solitary or single functioning kidney
- Evidence of urinary tract obstruction or hydronephrosis
- Multiple bilateral kidney cysts
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 48374
University of Texas at Southwestern
Dallas, Texas, 75390
Yale University
New Haven, Connecticut, 06520
About this study
Official title: Central Hub for Kidney Precision Medicine
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.
Read the detailed 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.
- Conditions
- Acute Kidney Failure, Acute Kidney Insufficiency, Acute Renal Failure, Acute Renal Injury, Acute Renal Insufficiency, Kidney Failure, Acute
- Medical subject headings
- Acute Kidney Injury, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Patients | The focus will be on patients with AKI in the setting of COVID-19 disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observational: Biorepository of Blood and Urine Specimens
Establish a biorepository of blood and urine specimens from patients with AKI in the setting of COVID-19 disease. For COVID-19 positive patients, in-hospital blood and in-hospital urine are collected within 24 hours of hospital admission. At a follow up visit 3 months after hospital admission, participants will be asked to participate in further bio-specimen collection and/or consent to participate in the main KPMP protocol.
Measured: Date of hospital admission through day 28 or hospital discharge [whichever is sooner]. Three month follow-up visit.
Observational: Biopsy-Related Outcomes
For patients who are scheduled for a clinically indicated kidney biopsy in the setting of COVID-19 disease, a segment of remnant tissue may be obtained. We will access the participant's pathology report and store images from their kidney biopsy in the KPMP Digital Pathology Repository. If there is no residual tissue available for analysis, the images will be stored in the KPMP Digital Pathology Repository.
Measured: During hospital visit or through study completion if participant wants to enroll into KPMP (up to 10 years, depending on enrollment date of participant)
Observational: Phenotypic Clinical Information
Collection of basic contact information, clinical phenotypic inpatient data relevant to kidney complication of COVID-19 infection, demographics, and linkage to external databases (NDI, USRDS, etc).
Measured: Date of hospital admission through day 28 or hospital discharge [whichever is sooner]
Observational: Longitudinal Follow-Up for KPMP Protocol
At a follow-up visit 3 months after hospital admission, participants will be asked to participate in further biospecimen collection and/or consent to participate in the main KPMP protocol.
Measured: Through study completion (up to 10 years, depending on enrollment date of participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start15 Jun 2021
- Primary completion30 Jun 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney FailureStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan, Icahn School of Medicine at Mount Sinai, Broad Institute of MIT and Harvard, Indiana University, Johns Hopkins University, Joslin Diabetes Center, Pacific Northwest National Laboratory, Princeton University, Stanford University, Ohio State University, University of California, San Diego, University of California, San Francisco, The University of Texas Health Science Center at San Antonio, University of Texas, Washington University School of Medicine, Yale University, Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Robyn McClelland, University of Washington
- Investigators
- Jonathan Himmelfarb, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384899
- Sponsor's protocol ID
- SITE00000750 (COV001)
- Other IDs
- 5U2CDK114886
- Status last verified
- May 2022
- First submitted
- 16 Jun 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Hub for Kidney Precision Medicine
- ClinicalTrials.gov ID
- NCT05384899
- Acronym / sponsor ID
- SITE00000750 (COV001)
- Conditions
- Acute Kidney Failure, Acute Kidney Insufficiency, Acute Renal Failure, Acute Renal Injury, Acute Renal Insufficiency, Kidney Failure, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan, Icahn School of Medicine at Mount Sinai, Broad Institute of MIT and Harvard, Indiana University, Johns Hopkins University, Joslin Diabetes Center, Pacific Northwest National Laboratory, Princeton University, Stanford University, Ohio State University, University of California, San Diego, University of California, San Francisco, The University of Texas Health Science Center at San Antonio, University of Texas, Washington University School of Medicine, Yale University, Beth Israel Deaconess Medical Center
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Patients | – | –The focus will be on patients with AKI in the setting of COVID-19 disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The KPMP will focus on COVID-19 positive in-hospital populations that account for large proportions of the public health burden of acute and chronic kidney diseases as evidenced by research and federal data.
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- Any potential participant meeting any one of the general or safety exclusion criteria will not be eligible for enrollment in the KPMP COVID-19 Substudy. Exclusion criteria include non-transient conditions that would not allow for enrollment in the main KPMP study.
- Non-English or Spanish language
- Less than 18 years of age
- Severe allergy to iodinated contrast
- Transplant recipient (kidney or non-kidney, including solid organ and bone marrow transplantation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Observational: Biorepository of Blood and Urine Specimens
Time frame: Date of hospital admission through day 28 or hospital discharge [whichever is sooner]. Three month follow-up visit.
Establish a biorepository of blood and urine specimens from patients with AKI in the setting of COVID-19 disease. For COVID-19 positive patients, in-hospital blood and in-hospital urine are collected within 24 hours of hospital admission. At a follow up visit 3 months after hospital admission, participants will be asked to participate in further bio-specimen collection and/or consent to participate in the main KPMP protocol.
Observational: Biopsy-Related Outcomes
Time frame: During hospital visit or through study completion if participant wants to enroll into KPMP (up to 10 years, depending on enrollment date of participant)
For patients who are scheduled for a clinically indicated kidney biopsy in the setting of COVID-19 disease, a segment of remnant tissue may be obtained. We will access the participant's pathology report and store images from their kidney biopsy in the KPMP Digital Pathology Repository. If there is no residual tissue available for analysis, the images will be stored in the KPMP Digital Pathology Repository.
Observational: Phenotypic Clinical Information
Time frame: Date of hospital admission through day 28 or hospital discharge [whichever is sooner]
Collection of basic contact information, clinical phenotypic inpatient data relevant to kidney complication of COVID-19 infection, demographics, and linkage to external databases (NDI, USRDS, etc).
Observational: Longitudinal Follow-Up for KPMP Protocol
Time frame: Through study completion (up to 10 years, depending on enrollment date of participant)
At a follow-up visit 3 months after hospital admission, participants will be asked to participate in further biospecimen collection and/or consent to participate in the main KPMP protocol.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Himmelfarb, MD principal investigator
University of Washington
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Failure and Acute Kidney Insufficiency, run by University of Washington at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observational: Biorepository of Blood and Urine Specimens (time frame: Date of hospital admission through day 28 or hospital discharge [whichever is sooner]. Three month follow-up visit.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.