CompletedNot Applicable

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

United States90 participantsStarted 2021-06-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Patients 18 years of age or older admitted to participating hospitals with a positive COVID-19 test result or Persons Under Investigation with suspected COVID-19 infection AND with AKI or at high risk of AKI in the setting of COVID-19 infection, as defined by any ONE of the following: * pre-existing chronic kidney disease as defined by eGFR less than 60 ml/min/1.73 m2 * history of diabetes mellitus established by at least one of the following criteria: * Hemoglobin A1C greater than or equal to 6.5%, confirmed with a repeat test within the past year * Fasting blood sugar greater than or equal to 126 mg/dL, confirmed with a repeat test within the past year * Use of glucose-lowering therapy (insulin or oral or other subcutaneous agents) * International Classification of Diseases (ICD) 9/10 diagnostic code for diabetes * requiring use of vasopressors * requiring use of mechanical ventilation AKI is defined by temporal changes in serum creatinine meeting KDIGO Stage 1 criteria or greater (0.3 rise in serum creatinine over baseline value). If a baseline serum creatinine is not available, the patient can be enrolled with an estimated Baseline serum creatinine (see KPMP COVID-19 Manual of Procedures table 1) Exclusion Criteria: 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…

What they're measuring

Observational: Biorepository of Blood and Urine Specimens

Timeframe: Date of hospital admission through day 28 or hospital discharge [whichever is sooner]. Three month follow-up visit.

Observational: Biopsy-Related Outcomes

Timeframe: 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

Timeframe: Date of hospital admission through day 28 or hospital discharge [whichever is sooner]

Observational: Longitudinal Follow-Up for KPMP Protocol

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

Trial details

NCT IDNCT05384899

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-06-30

View on ClinicalTrials.gov More Acute Kidney Failure trials