<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/NCT04482153</url>
  </required_header>
  <id_info>
    <org_study_id>NAFLD inCKD</org_study_id>
    <nct_id>NCT04482153</nct_id>
  </id_info>
  <brief_title>Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut University Hospitals</brief_title>
  <official_title>Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut University Hospitals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our study is:&#xD;
&#xD;
        1. The early detection of NAFLD in CKD patients with different stages (stage I to IV) to&#xD;
           avoid progression to liver fibrosis.&#xD;
&#xD;
        2. Evaluation of the relationship between the severity of fatty liver in NAFLD assessed by&#xD;
           liver enzymes, biochemical markers, ultrasonography and grades of Fibroscan with CKD&#xD;
           staging, eGFR and proteinuria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic kidney disease (CKD) is defined as presence of reduced glomerular filtration rate&#xD;
      (GFR) &lt; 60 ml/min/ 1.73 m2 and/or evidence of kidney damage (usually indicated by albuminuria&#xD;
      or proteinuria) for &gt; 3 months or more irrespective of cause . CKD stages are classified&#xD;
      according to the National Kidney Foundation in to five stages according to estimated GFR .&#xD;
&#xD;
      The prevalence of CKD is continuously rising in concert with the rising epidemic of its risk&#xD;
      factors including ageing, diabetes, obesity, metabolic syndrome, smoking, and hypertension .&#xD;
&#xD;
      Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases in&#xD;
      Western countries. It encompasses a spectrum of conditions with lipid deposition in&#xD;
      hepatocytes, ranging from simple steatosis to non-alcoholic steatohepatitis (NASH).&#xD;
&#xD;
      It is defined as fatty liver with inflammation and hepatocelullar injury with or without&#xD;
      fibrosis, advanced fibrosis and cirrhosis. Metabolic syndrome with its clinical traits is&#xD;
      highly prevalent in patients with NAFLD .&#xD;
&#xD;
      Preliminary data suggest an association between CKD and NAFLD .reported that the prevalence&#xD;
      of CKD was significantly higher in patients with NASH compared to patients without NASH.&#xD;
&#xD;
      Moreover, Yassui k documented the presence of moderately decreased eGFR and high frequency of&#xD;
      micro-albuminuria in patients with biopsy proven NASH.&#xD;
&#xD;
      The diagnosis of NAFLD/NASH is based on the gold standard of liver biopsy or less reliably on&#xD;
      serum liver enzymes or ultrasound imaging. However, liver biopsy has its limitations: apart&#xD;
      from being an invasive procedure, connected with serious complications .&#xD;
&#xD;
      Many non-invasive procedures have been intensively applied to detect hepatic steatosis and&#xD;
      fibrosis. The Controlled Attenuation Parameter (CAP) can using transient elastography (TE)&#xD;
      (Fibroscan®) permits to efficiently separate different grades of severity of steatosis. CAP&#xD;
      is based on the properties of ultrasonic signals acquired by the Fibroscan®. It allows to&#xD;
      simultaneously measure liver stiffness and CAP in the same liver volume.&#xD;
&#xD;
      The volume used for the measurement by the Fibroscan® is 200 times larger than that of a&#xD;
      liver biopsy specimen. Therefore the Fibroscan® is used more and more in clinical practice .&#xD;
&#xD;
      Many biochemical markers can be used for diagnosis of NAFLD such as tissue inhibitor of&#xD;
      metalloproteinase 1 (TIMP1), aminoterminal peptide of procollagen III (P3NP) .&#xD;
&#xD;
      Up till now, the relationship between NAFLD and CKD is still poorly understood and under&#xD;
      discussed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The early detection of NAFLD in CKD patients with different stages (stage I to IV) to avoid progression to liver fibrosis.</measure>
    <time_frame>1 year</time_frame>
    <description>The early detection of NAFLD in CKD patients with different stages (stage I to IV) to avoid progression to liver fibrosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the relationship between the severity of fatty liver in NAFLD assessed by liver enzymes, biochemical markers, ultrasonography and grades of Fibroscan with CKD staging, eGFR and proteinuria.</measure>
    <time_frame>1year</time_frame>
    <description>Evaluation of the relationship between the severity of fatty liver in NAFLD assessed by liver enzymes, biochemical markers, ultrasonography and grades of Fibroscan with CKD staging, eGFR and proteinuria.</description>
  </primary_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Study of the NAFLD in CKD Patients Using Fibroscan Study</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>fibroscan</intervention_name>
    <description>The Controlled Attenuation Parameter (CAP) can using transient elastography (TE) (Fibroscan®) permits to efficiently separate different grades of severity of steatosis. CAP is based on the properties of ultrasonic signals acquired by the Fibroscan®. It allows to simultaneously measure liver stiffness and CAP in the same liver volume.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Eighty CKD patients with different stages (stage I to IV) according to the National Kidney&#xD;
        Foundation are recruited from inpatients of renal unit in internal medicine department,&#xD;
        Assuit university hospitals. Their GFR will assessed by using CKD EPI&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Eighty CKD patients with different stages (stage I to IV) according to the National&#xD;
        Kidney Foundation are recruited from inpatients of renal unit in internal medicine&#xD;
        department, Assuit university hospitals. Their GFR will assessed by using CKD EPI equation&#xD;
        measured as GFR=166 x(s cr/0.7)-1.209X(0.993)age if female, and GFR=163X(s&#xD;
        cr/0.9)-1.209x(0.993)age if male. (Andrews et al 2009).&#xD;
&#xD;
        CKD staging according to GFR by CKD EPI is:&#xD;
&#xD;
          -  Stage1 in which GFR&gt;90 mil/min but evidence of kidney damage.&#xD;
&#xD;
          -  Stage 2 GFR 60-89 mil/min.&#xD;
&#xD;
          -  Stage 3 GFR 30-95 mil/min.&#xD;
&#xD;
          -  Stage 4 GFR 15-29 mil/min.&#xD;
&#xD;
          -  Stage 5 GFR&lt;15 mil/min. The patients will be enrolled from October 2020 to October&#xD;
             2021.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1- All Patients with positive hepatitis C virus antibodies. 2- All Patients with&#xD;
             positive hepatitis B surface antigen. 3- Congested liver. 4- Drug induced&#xD;
             hepatosteatosis (INH, estrogens, methotrexate, steroids, amiodarone, etc.).&#xD;
&#xD;
             5- Autoimmune liver diseases. 6- Metabolic liver diseases. 7- Alcoholic liver disease.&#xD;
             8- Malignancy. 9- ESRD (stage V) on hemodialysis. 10- Obesity overweight BMI &gt; 30. 11-&#xD;
             Metabolic syndrome. 12- Type II DM.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>marwa ahmed, resident doctor</last_name>
    <phone>01140291416</phone>
    <email>marwa011398@med.au.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>effat tony, proffessor</last_name>
    <phone>01097330309</phone>
    <email>effattony@gmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Dowman JK, Tomlinson JW, Newsome PN. Systematic review: the diagnosis and staging of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. Aliment Pharmacol Ther. 2011 Mar;33(5):525-40. doi: 10.1111/j.1365-2036.2010.04556.x. Epub 2010 Dec 29.</citation>
    <PMID>21198708</PMID>
  </reference>
  <reference>
    <citation>Guha IN, Parkes J, Roderick P, Chattopadhyay D, Cross R, Harris S, Kaye P, Burt AD, Ryder SD, Aithal GP, Day CP, Rosenberg WM. Noninvasive markers of fibrosis in nonalcoholic fatty liver disease: Validating the European Liver Fibrosis Panel and exploring simple markers. Hepatology. 2008 Feb;47(2):455-60. doi: 10.1002/hep.21984.</citation>
    <PMID>18038452</PMID>
  </reference>
  <reference>
    <citation>Hamad AA, Khalil AA, Connolly V, Ahmed MH. Relationship between non-alcoholic fatty liver disease and kidney function: a communication between two organs that needs further exploration. Arab J Gastroenterol. 2012 Dec;13(4):161-5. doi: 10.1016/j.ajg.2012.06.010. Epub 2012 Sep 10.</citation>
    <PMID>23432982</PMID>
  </reference>
  <reference>
    <citation>Ikizler TA. CKD classification: time to move beyond KDOQI. J Am Soc Nephrol. 2009 May;20(5):929-30. doi: 10.1681/ASN.2009030309. Epub 2009 Apr 23. No abstract available.</citation>
    <PMID>19389841</PMID>
  </reference>
  <reference>
    <citation>Kiapidou S, Liava C, Kalogirou M, Akriviadis E, Sinakos E. Chronic kidney disease in patients with non-alcoholic fatty liver disease: What the Hepatologist should know? Ann Hepatol. 2020 Mar-Apr;19(2):134-144. doi: 10.1016/j.aohep.2019.07.013. Epub 2019 Sep 23.</citation>
    <PMID>31606352</PMID>
  </reference>
  <reference>
    <citation>Martinez SM, Crespo G, Navasa M, Forns X. Noninvasive assessment of liver fibrosis. Hepatology. 2011 Jan;53(1):325-35. doi: 10.1002/hep.24013. Epub 2010 Nov 29.</citation>
    <PMID>21254180</PMID>
  </reference>
  <reference>
    <citation>McCullough K, Sharma P, Ali T, Khan I, Smith WC, MacLeod A, Black C. Measuring the population burden of chronic kidney disease: a systematic literature review of the estimated prevalence of impaired kidney function. Nephrol Dial Transplant. 2012 May;27(5):1812-21. doi: 10.1093/ndt/gfr547. Epub 2011 Sep 29.</citation>
    <PMID>21965592</PMID>
  </reference>
  <reference>
    <citation>Shah B, Sucher K, Hollenbeck CB. Comparison of ideal body weight equations and published height-weight tables with body mass index tables for healthy adults in the United States. Nutr Clin Pract. 2006 Jun;21(3):312-9. doi: 10.1177/0115426506021003312.</citation>
    <PMID>16772549</PMID>
  </reference>
  <reference>
    <citation>Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.</citation>
    <PMID>23732715</PMID>
  </reference>
  <reference>
    <citation>Thomas G, Sehgal AR, Kashyap SR, Srinivas TR, Kirwan JP, Navaneethan SD. Metabolic syndrome and kidney disease: a systematic review and meta-analysis. Clin J Am Soc Nephrol. 2011 Oct;6(10):2364-73. doi: 10.2215/CJN.02180311. Epub 2011 Aug 18.</citation>
    <PMID>21852664</PMID>
  </reference>
  <reference>
    <citation>Yasui K, Sumida Y, Mori Y, Mitsuyoshi H, Minami M, Itoh Y, Kanemasa K, Matsubara H, Okanoue T, Yoshikawa T. Nonalcoholic steatohepatitis and increased risk of chronic kidney disease. Metabolism. 2011 May;60(5):735-9. doi: 10.1016/j.metabol.2010.07.022. Epub 2010 Sep 3.</citation>
    <PMID>20817213</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Marwa Ahmed</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <!-- 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/NCT04482153
org study id: NAFLD inCKD
nct id: NCT04482153
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of our study is:

        1. The early detection of NAFLD in CKD patients with different stages (stage I to IV) to
           avoid progression to liver fibrosis.

        2. Evaluation of the relationship between the severity of fatty liver in NAFLD assessed by
           liver enzymes, biochemical markers, ultrasonography and grades of Fibroscan with CKD
           staging, eGFR and proteinuria.
Chronic kidney disease (CKD) is defined as presence of reduced glomerular filtration rate
      (GFR) < 60 ml/min/ 1.73 m2 and/or evidence of kidney damage (usually indicated by albuminuria
      or proteinuria) for > 3 months or more irrespective of cause . CKD stages are classified
      according to the National Kidney Foundation in to five stages according to estimated GFR .

      The prevalence of CKD is continuously rising in concert with the rising epidemic of its risk
      factors including ageing, diabetes, obesity, metabolic syndrome, smoking, and hypertension .

      Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases in
      Western countries. It encompasses a spectrum of conditions with lipid deposition in
      hepatocytes, ranging from simple steatosis to non-alcoholic steatohepatitis (NASH).

      It is defined as fatty liver with inflammation and hepatocelullar injury with or without
      fibrosis, advanced fibrosis and cirrhosis. Metabolic syndrome with its clinical traits is
      highly prevalent in patients with NAFLD .

      Preliminary data suggest an association between CKD and NAFLD .reported that the prevalence
      of CKD was significantly higher in patients with NASH compared to patients without NASH.

      Moreover, Yassui k documented the presence of moderately decreased eGFR and high frequency of
      micro-albuminuria in patients with biopsy proven NASH.

      The diagnosis of NAFLD/NASH is based on the gold standard of liver biopsy or less reliably on
      serum liver enzymes or ultrasound imaging. However, liver biopsy has its limitations: apart
      from being an invasive procedure, connected with serious complications .

      Many non-invasive procedures have been intensively applied to detect hepatic steatosis and
      fibrosis. The Controlled Attenuation Parameter (CAP) can using transient elastography (TE)
      (Fibroscan®) permits to efficiently separate different grades of severity of steatosis. CAP
      is based on the properties of ultrasonic signals acquired by the Fibroscan®. It allows to
      simultaneously measure liver stiffness and CAP in the same liver volume.

      The volume used for the measurement by the Fibroscan® is 200 times larger than that of a
      liver biopsy specimen. Therefore the Fibroscan® is used more and more in clinical practice .

      Many biochemical markers can be used for diagnosis of NAFLD such as tissue inhibitor of
      metalloproteinase 1 (TIMP1), aminoterminal peptide of procollagen III (P3NP) .

      Up till now, the relationship between NAFLD and CKD is still poorly understood and under
      discussed.
observational model: Case-Only
time perspective: Other
measure: The early detection of NAFLD in CKD patients with different stages (stage I to IV) to avoid progression to liver fibrosis.
time frame: 1 year
description: The early detection of NAFLD in CKD patients with different stages (stage I to IV) to avoid progression to liver fibrosis.
measure: Evaluation of the relationship between the severity of fatty liver in NAFLD assessed by liver enzymes, biochemical markers, ultrasonography and grades of Fibroscan with CKD staging, eGFR and proteinuria.
time frame: 1year
description: Evaluation of the relationship between the severity of fatty liver in NAFLD assessed by liver enzymes, biochemical markers, ultrasonography and grades of Fibroscan with CKD staging, eGFR and proteinuria.
intervention type: Device
intervention name: fibroscan
description: The Controlled Attenuation Parameter (CAP) can using transient elastography (TE) (Fibroscan®) permits to efficiently separate different grades of severity of steatosis. CAP is based on the properties of ultrasonic signals acquired by the Fibroscan®. It allows to simultaneously measure liver stiffness and CAP in the same liver volume.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
last name: marwa ahmed, resident doctor
phone: 01140291416
email: marwa011398@med.au.edu.eg
last name: effat tony, proffessor
phone: 01097330309
email: effattony@gmail.com
citation: Dowman JK, Tomlinson JW, Newsome PN. Systematic review: the diagnosis and staging of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. Aliment Pharmacol Ther. 2011 Mar;33(5):525-40. doi: 10.1111/j.1365-2036.2010.04556.x. Epub 2010 Dec 29.
PMID: 21198708
citation: Guha IN, Parkes J, Roderick P, Chattopadhyay D, Cross R, Harris S, Kaye P, Burt AD, Ryder SD, Aithal GP, Day CP, Rosenberg WM. Noninvasive markers of fibrosis in nonalcoholic fatty liver disease: Validating the European Liver Fibrosis Panel and exploring simple markers. Hepatology. 2008 Feb;47(2):455-60. doi: 10.1002/hep.21984.
PMID: 18038452
citation: Hamad AA, Khalil AA, Connolly V, Ahmed MH. Relationship between non-alcoholic fatty liver disease and kidney function: a communication between two organs that needs further exploration. Arab J Gastroenterol. 2012 Dec;13(4):161-5. doi: 10.1016/j.ajg.2012.06.010. Epub 2012 Sep 10.
PMID: 23432982
citation: Ikizler TA. CKD classification: time to move beyond KDOQI. J Am Soc Nephrol. 2009 May;20(5):929-30. doi: 10.1681/ASN.2009030309. Epub 2009 Apr 23. No abstract available.
PMID: 19389841
citation: Kiapidou S, Liava C, Kalogirou M, Akriviadis E, Sinakos E. Chronic kidney disease in patients with non-alcoholic fatty liver disease: What the Hepatologist should know? Ann Hepatol. 2020 Mar-Apr;19(2):134-144. doi: 10.1016/j.aohep.2019.07.013. Epub 2019 Sep 23.
PMID: 31606352
citation: Martinez SM, Crespo G, Navasa M, Forns X. Noninvasive assessment of liver fibrosis. Hepatology. 2011 Jan;53(1):325-35. doi: 10.1002/hep.24013. Epub 2010 Nov 29.
PMID: 21254180
citation: McCullough K, Sharma P, Ali T, Khan I, Smith WC, MacLeod A, Black C. Measuring the population burden of chronic kidney disease: a systematic literature review of the estimated prevalence of impaired kidney function. Nephrol Dial Transplant. 2012 May;27(5):1812-21. doi: 10.1093/ndt/gfr547. Epub 2011 Sep 29.
PMID: 21965592
citation: Shah B, Sucher K, Hollenbeck CB. Comparison of ideal body weight equations and published height-weight tables with body mass index tables for healthy adults in the United States. Nutr Clin Pract. 2006 Jun;21(3):312-9. doi: 10.1177/0115426506021003312.
PMID: 16772549
citation: Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.
PMID: 23732715
citation: Thomas G, Sehgal AR, Kashyap SR, Srinivas TR, Kirwan JP, Navaneethan SD. Metabolic syndrome and kidney disease: a systematic review and meta-analysis. Clin J Am Soc Nephrol. 2011 Oct;6(10):2364-73. doi: 10.2215/CJN.02180311. Epub 2011 Aug 18.
PMID: 21852664
citation: Yasui K, Sumida Y, Mori Y, Mitsuyoshi H, Minami M, Itoh Y, Kanemasa K, Matsubara H, Okanoue T, Yoshikawa T. Nonalcoholic steatohepatitis and increased risk of chronic kidney disease. Metabolism. 2011 May;60(5):735-9. doi: 10.1016/j.metabol.2010.07.022. Epub 2010 Sep 3.
PMID: 20817213
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Marwa Ahmed
investigator title: Principal investigator
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic