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

NCT05384899 | Completed DMC

• 2 other identifiers: SITE00000750 (COV001)5U2CDK114886
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Acute Renal Failure; Acute Renal Injury; Acute Renal Insufficiency; Kidney Failure, Acute; Kidney Insufficiency, Acute; Renal Failure, Acute; Renal Insufficiency, Acute; Covid19; Sars-CoV-2 Infection; Acute Kidney Failure; Acute Kidney Insufficiency

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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.

  Through study completion (up to 10 years, depending on enrollment date of participant)

Study Arms (1)

COVID-19 Patients

The focus will be on patients with AKI in the setting of COVID-19 disease.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Washington: lead
• University of Michigan: collaborator
• Indiana University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• Broad Institute of MIT and Harvard: collaborator
• Johns Hopkins University: collaborator
• Joslin Diabetes Center: collaborator
• Pacific Northwest National Laboratory: collaborator
• Princeton University: collaborator
• Stanford University: collaborator
• Ohio State University: collaborator
• University of California, San Diego: collaborator
• University of California, San Francisco: 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
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (4)

Yale University

New Haven, Connecticut, 06520, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 48374, United States

Location

University of Texas at Southwestern

Dallas, Texas, 75390, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

In-hospital blood collection and in-hospital urine collection will be obtained. Collection of remnant kidney (renal) tissue from clinically indicated kidney biopsies in the setting of COVID-19 disease.

MeSH Terms

Conditions

Acute Kidney Injury; COVID-19

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jonathan Himmelfarb, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor, School of Public Health: Biostatistics

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: May 20, 2022
• Study Start: June 15, 2021
• Primary Completion: June 30, 2022
• Study Completion: October 30, 2022
• Last Updated: April 23, 2026

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)