<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04491227</url>
  </required_header>
  <id_info>
    <org_study_id>000295</org_study_id>
    <nct_id>NCT04491227</nct_id>
  </id_info>
  <brief_title>Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection</brief_title>
  <official_title>Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The coronavirus (COVID-19) pandemic has created a significant strain on health care resources&#xD;
      across the world for managing critically ill patients. Emerging reports from China, South&#xD;
      Korea and Italy have reported varying incidence of acute kidney (AKI) ranging from 5-15% with&#xD;
      a mortality of 60-80% however there is no systematic assessment of the risk factors,&#xD;
      recognition, course and outcomes in patients with and without kidney disease whose course is&#xD;
      complicated by AKI1-4. Patients with underlying CKD, immunosuppressed patients with renal&#xD;
      transplants and ESKD patients are at high risk for COVID-19 infection and there is limited&#xD;
      information on the effect of COVID-19 on the course and outcomes of these patients. The&#xD;
      requirement for renal support including IHD, CRRT and sorbent based therapies has been&#xD;
      variable and has contributed to the intense pressure on the nephrology and critical care&#xD;
      providers for delivering these therapies. As the COVID-19 pandemic expands in the USA and&#xD;
      abroad, there is an intense need to understand the epidemiology of the disease and the&#xD;
      resources needed for renal support to inform clinical management and public health&#xD;
      interventions.&#xD;
&#xD;
      In this study, the investigators aim to investigate health care facilities across the world&#xD;
      (hospital wards, ICU, outpatient clinics, nursing homes, healthcare centers) to draw a global&#xD;
      picture of incidence, risk factors, resources available for treatment and prognosis of acute&#xD;
      and chronic kidney disease in patient with COVID 19 confirmed infection. The aim is to&#xD;
      identify trends in patients with acute and chronic kidney disease, determine its incidence,&#xD;
      treatment and outcomes in different settings across the world. This information will be used&#xD;
      to develop and implement educational tools and resources to prevent deaths from AKI and&#xD;
      progression of CKD in this and following pandemics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute and Chronic kidney diseases are important causes of mortality and morbidity worldwide.&#xD;
      The associated socioeconomic burden of kidney disease and AKI, as in some cases recovery is&#xD;
      incomplete and chronic kidney disease (CKD) can arise, is a growing problem around the world.&#xD;
      During the COVID 19 pandemic the incidence of AKI has been reported to be as low as 0.5% to&#xD;
      as high as 23%. AKI was reported to develop at a median of 15 days in one study, and another&#xD;
      study reported that most AKI developed within 7 days of admission. The data on acute kidney&#xD;
      injury (AKI) in patients with COVID-19 is mostly from patients who are hospitalized, and in&#xD;
      some studies limited to critically ill patients in the ICU. In ICU patients the requirement&#xD;
      for renal support and mortality is reported to be high, however is a lack of epidemiological&#xD;
      studies specifically designed to determine the impact of COVID 19 on kidney outcomes.&#xD;
&#xD;
      The mortality rate of patients with kidney dysfunction varies widely and is inversely related&#xD;
      to country income and percentage of gross domestic product spent on total health expenditure.&#xD;
      Several initiatives will be very insightful and identified important gaps in knowledge, more&#xD;
      effort is required to understand this problem affecting all regions of the globe. In order to&#xD;
      eventually implement resources and tools to help prevent, diagnose and treat patients with&#xD;
      COVID 19 infection and kidney dysfunction, the investigators need to understand its&#xD;
      incidence, risk factors, available resources and barriers to diagnosis and treatment.&#xD;
&#xD;
      This project will collect data on kidney function progression in patients infected with COVID&#xD;
      19 across the world. The study will open to individual physicians across the world who agreed&#xD;
      to participate by providing de-identified clinical and lab data of patients with confirmed&#xD;
      COVID 19 infection with acute and chronic kidney dysfunction.&#xD;
&#xD;
      Primary Objectives:&#xD;
&#xD;
      1. Establish incidence and outcomes of acute kidney injury (AKI) in different settings&#xD;
      worldwide during the COVID 19 pandemic.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        1. Compare risk factors, etiologies, diagnosis, management and outcomes of acute and&#xD;
           chronic kidney dysfunction in COVID 19 patients in different countries&#xD;
&#xD;
        2. Determine resources available for recognition, non-dialytic and dialytic management and&#xD;
           follow up of patients with acute and chronic kidney dysfunction and COVID 19 infection&#xD;
           in different settings and countries.&#xD;
&#xD;
        3. Determine long term outcomes, 6 months and 1 year, of patients with acute and chronic&#xD;
           kidney dysfunction and COVID 19 infection in different settings.&#xD;
&#xD;
        4. Evaluate barriers preventing access to the standard treatments of acute and chronic&#xD;
           kidney dysfunction and COVID 19 infection across different countries.&#xD;
&#xD;
        5. Determine the impact of COVID 19 infection on the progression of acute and chronic&#xD;
           kidney disease in patient with native and transplanted kidney.&#xD;
&#xD;
        6. Evaluate the treatment strategies of patient with ESKD on hospitalized patients with&#xD;
           COVID 19.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">May 5, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>AKI incidence</measure>
    <time_frame>from hospital admission through hospital discharge upto 24 weeks</time_frame>
    <description>Meeting of at least one of the modified KDIGO Criteria&#xD;
Increase or decrease in serum creatinine &gt;0.3 mg/dl from reference in 48 hours&#xD;
Increase or decrease in serum creatinine &gt; 50% from reference in 7 days&#xD;
Urine output &lt; 400 ml/day</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dialysis requirement</measure>
    <time_frame>through study completion upto 1 year from enrollment</time_frame>
    <description>initiation of intermittent hemodialysis, continuous hemodialysis or peritoneal dialysis during the hospital stay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hospital mortality</measure>
    <time_frame>through study completion within 1 year</time_frame>
    <description>Deaths during primary hospitalization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal functional recovery</measure>
    <time_frame>Assessed at at 3, 6 and 12 months from enrollment at hospital admission</time_frame>
    <description>C-Complete: SCr &lt; 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent C-Complete: SCr &lt; 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent Percentage of patinets with renal functioanl recovery based on serum creatinien levels classfied as C-Complete: SCr &lt; 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional status</measure>
    <time_frame>questionnaires to be completed at 3, 6 and 12 months from enrollment at hospital admission</time_frame>
    <description>EQL5D scale and SH8 scales completed at 3, 6 and 12 months post enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resource utilization</measure>
    <time_frame>Within 1 year of enrollment for primary hospitalization</time_frame>
    <description>Number of days patient is in the hospital and ICU and is managed with ventilators, dialysis or other extracorporeal organ support e.g. ECMO during the hospital stay</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Covid19</condition>
  <condition>AKI</condition>
  <condition>CKD</condition>
  <condition>ESRD</condition>
  <condition>Transplant;Failure,Kidney</condition>
  <arm_group>
    <arm_group_label>Kidney disease in COVID-19</arm_group_label>
    <description>Chronic Kidney Disease (CKD): Known diagnosis of chronic kidney disease; prior evidence of markers of kidney damage for 3 months (microalbuminuria, proteinuria &gt;300mg/24 hrs or abnormalities in imaging tests) or the presence of glomerular filtration rate (GFR) &lt;60 mL/min/1.73 m2 for 3 months calculated with CKD-EPI equation, with or without other signs of kidney damage as described above.&#xD;
ESKD: Patients that are dialysis dependent.&#xD;
Suspected AKI: Oliguria (&lt;200 mL/6 hours) and any AKI-related clinical signs or symptoms (see table 1) or urinalysis/dipstick abnormality. All suspected AKI cases must be confirmed prior to enrollment.&#xD;
Confirmed AKI: Meeting of at least one of the modified KDIGO Criteria&#xD;
Increase or decrease in serum creatinine &gt;0.3 mg/dl from reference in 48 hours&#xD;
Increase or decrease in serum creatinine &gt; 50% from reference in 7 days&#xD;
Urine output &lt; 400 ml/day&#xD;
Functioning Kidney transplant:</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with confirmed COVID 19 infection with acute and chronic kidney dysfunction.&#xD;
&#xD;
        Patients testing positive for COVID19 who meet criteria for AKI, have known CKD (with&#xD;
        baseline eGFR less than 60), are ESKD on dialysis or kidney transplant recipients will be&#xD;
        enrolled in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with confirmed infection with COVID 19&#xD;
&#xD;
          -  Patients with Acute Kidney injury (AKI) or Chronic kidney disease (CKD) or need for&#xD;
             dialysis&#xD;
&#xD;
          -  Patients receiving Chronic dialysis (hemo or peritoneal dialysis)&#xD;
&#xD;
          -  Renal transplant recipients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Patients &lt; 18 yrs age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ravindra L Mehta</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama, Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Peter's Hospital</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacobi Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Obrero #2</name>
      <address>
        <city>Cochabamba</city>
        <country>Bolivia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Sacre Coeur &amp; Universite de Montreal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidad de Los Andes</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Postgraduate Institute of Research, Chandigarh</name>
      <address>
        <city>Chandigarh</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's &amp; St Thomas's Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nottingham</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2RD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bolivia</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>India</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Ravindra Mehta</investigator_full_name>
    <investigator_title>Recall Faculty</investigator_title>
  </responsible_party>
  <keyword>AKI</keyword>
  <keyword>dialysis</keyword>
  <keyword>CKD</keyword>
  <keyword>COVID19</keyword>
  <keyword>renal transplant</keyword>
  <keyword>mortality</keyword>
  <keyword>renal recovery</keyword>
  <keyword>resource utilization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Participating sites will have acess to their own data and aggregate data</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04491227
org study id: 000295
nct id: NCT04491227
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The coronavirus (COVID-19) pandemic has created a significant strain on health care resources
      across the world for managing critically ill patients. Emerging reports from China, South
      Korea and Italy have reported varying incidence of acute kidney (AKI) ranging from 5-15% with
      a mortality of 60-80% however there is no systematic assessment of the risk factors,
      recognition, course and outcomes in patients with and without kidney disease whose course is
      complicated by AKI1-4. Patients with underlying CKD, immunosuppressed patients with renal
      transplants and ESKD patients are at high risk for COVID-19 infection and there is limited
      information on the effect of COVID-19 on the course and outcomes of these patients. The
      requirement for renal support including IHD, CRRT and sorbent based therapies has been
      variable and has contributed to the intense pressure on the nephrology and critical care
      providers for delivering these therapies. As the COVID-19 pandemic expands in the USA and
      abroad, there is an intense need to understand the epidemiology of the disease and the
      resources needed for renal support to inform clinical management and public health
      interventions.

      In this study, the investigators aim to investigate health care facilities across the world
      (hospital wards, ICU, outpatient clinics, nursing homes, healthcare centers) to draw a global
      picture of incidence, risk factors, resources available for treatment and prognosis of acute
      and chronic kidney disease in patient with COVID 19 confirmed infection. The aim is to
      identify trends in patients with acute and chronic kidney disease, determine its incidence,
      treatment and outcomes in different settings across the world. This information will be used
      to develop and implement educational tools and resources to prevent deaths from AKI and
      progression of CKD in this and following pandemics.
Acute and Chronic kidney diseases are important causes of mortality and morbidity worldwide.
      The associated socioeconomic burden of kidney disease and AKI, as in some cases recovery is
      incomplete and chronic kidney disease (CKD) can arise, is a growing problem around the world.
      During the COVID 19 pandemic the incidence of AKI has been reported to be as low as 0.5% to
      as high as 23%. AKI was reported to develop at a median of 15 days in one study, and another
      study reported that most AKI developed within 7 days of admission. The data on acute kidney
      injury (AKI) in patients with COVID-19 is mostly from patients who are hospitalized, and in
      some studies limited to critically ill patients in the ICU. In ICU patients the requirement
      for renal support and mortality is reported to be high, however is a lack of epidemiological
      studies specifically designed to determine the impact of COVID 19 on kidney outcomes.

      The mortality rate of patients with kidney dysfunction varies widely and is inversely related
      to country income and percentage of gross domestic product spent on total health expenditure.
      Several initiatives will be very insightful and identified important gaps in knowledge, more
      effort is required to understand this problem affecting all regions of the globe. In order to
      eventually implement resources and tools to help prevent, diagnose and treat patients with
      COVID 19 infection and kidney dysfunction, the investigators need to understand its
      incidence, risk factors, available resources and barriers to diagnosis and treatment.

      This project will collect data on kidney function progression in patients infected with COVID
      19 across the world. The study will open to individual physicians across the world who agreed
      to participate by providing de-identified clinical and lab data of patients with confirmed
      COVID 19 infection with acute and chronic kidney dysfunction.

      Primary Objectives:

      1. Establish incidence and outcomes of acute kidney injury (AKI) in different settings
      worldwide during the COVID 19 pandemic.

      Secondary Objectives:

        1. Compare risk factors, etiologies, diagnosis, management and outcomes of acute and
           chronic kidney dysfunction in COVID 19 patients in different countries

        2. Determine resources available for recognition, non-dialytic and dialytic management and
           follow up of patients with acute and chronic kidney dysfunction and COVID 19 infection
           in different settings and countries.

        3. Determine long term outcomes, 6 months and 1 year, of patients with acute and chronic
           kidney dysfunction and COVID 19 infection in different settings.

        4. Evaluate barriers preventing access to the standard treatments of acute and chronic
           kidney dysfunction and COVID 19 infection across different countries.

        5. Determine the impact of COVID 19 infection on the progression of acute and chronic
           kidney disease in patient with native and transplanted kidney.

        6. Evaluate the treatment strategies of patient with ESKD on hospitalized patients with
           COVID 19.
observational model: Cohort
time perspective: Retrospective
measure: AKI incidence
time frame: from hospital admission through hospital discharge upto 24 weeks
description: Meeting of at least one of the modified KDIGO Criteria
Increase or decrease in serum creatinine >0.3 mg/dl from reference in 48 hours
Increase or decrease in serum creatinine > 50% from reference in 7 days
Urine output < 400 ml/day
measure: Dialysis requirement
time frame: through study completion upto 1 year from enrollment
description: initiation of intermittent hemodialysis, continuous hemodialysis or peritoneal dialysis during the hospital stay
measure: hospital mortality
time frame: through study completion within 1 year
description: Deaths during primary hospitalization
measure: Renal functional recovery
time frame: Assessed at at 3, 6 and 12 months from enrollment at hospital admission
description: C-Complete: SCr < 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent C-Complete: SCr < 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent Percentage of patinets with renal functioanl recovery based on serum creatinien levels classfied as C-Complete: SCr < 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent
measure: Functional status
time frame: questionnaires to be completed at 3, 6 and 12 months from enrollment at hospital admission
description: EQL5D scale and SH8 scales completed at 3, 6 and 12 months post enrollment
measure: Resource utilization
time frame: Within 1 year of enrollment for primary hospitalization
description: Number of days patient is in the hospital and ICU and is managed with ventilators, dialysis or other extracorporeal organ support e.g. ECMO during the hospital stay
arm group label: Kidney disease in COVID-19
description: Chronic Kidney Disease (CKD): Known diagnosis of chronic kidney disease; prior evidence of markers of kidney damage for 3 months (microalbuminuria, proteinuria >300mg/24 hrs or abnormalities in imaging tests) or the presence of glomerular filtration rate (GFR) <60 mL/min/1.73 m2 for 3 months calculated with CKD-EPI equation, with or without other signs of kidney damage as described above.
ESKD: Patients that are dialysis dependent.
Suspected AKI: Oliguria (<200 mL/6 hours) and any AKI-related clinical signs or symptoms (see table 1) or urinalysis/dipstick abnormality. All suspected AKI cases must be confirmed prior to enrollment.
Confirmed AKI: Meeting of at least one of the modified KDIGO Criteria
Increase or decrease in serum creatinine >0.3 mg/dl from reference in 48 hours
Increase or decrease in serum creatinine > 50% from reference in 7 days
Urine output < 400 ml/day
Functioning Kidney transplant:
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ravindra L Mehta
role: Principal Investigator
affiliation: University of California, San Diego
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Bolivia
country: Canada
country: Chile
country: India
country: United Kingdom
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Ravindra Mehta
investigator title: Recall Faculty
mesh term: COVID-19
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Renal Insufficiency
sharing ipd: No
ipd description: Participating sites will have acess to their own data and aggregate data