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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
2
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)
3
Observational: Phenotypic Clinical Information
Timeframe: Date of hospital admission through day 28 or hospital discharge [whichever is sooner]
4
Observational: Longitudinal Follow-Up for KPMP Protocol
Timeframe: Through study completion (up to 10 years, depending on enrollment date of participant)