<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/NCT04439747</url>
  </required_header>
  <id_info>
    <org_study_id>20180438</org_study_id>
    <nct_id>NCT04439747</nct_id>
  </id_info>
  <brief_title>Develop and Implement Methods for Diagnostic and Treatment of Hormonal Disorders in Patients With Chronic Kidney Disease</brief_title>
  <official_title>Develop and Implement Methods for Diagnostic and Treatment of Hormonal Disorders in Patients With Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Belarusian State Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Belarusian State Medical University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Methods of diagnostic and treatment of hormonal disorders in patients with chronic kidney&#xD;
      disease (CKD) will be developed and implemented in real clinical practice. As a result of the&#xD;
      project, new scientific data will be obtained on the relationship of hyperprolactinemia and&#xD;
      impaired functioning of the pituitary-gonadal axis, changes in functioning of the&#xD;
      renin-angiotensin-aldosterone system will be revealed, and the characteristics of the thyroid&#xD;
      and parathyroid status in patients with CKD will be determined, including receiving renal&#xD;
      replacement therapy (RRT) and after kidney transplantation, which will improve the efficiency&#xD;
      of diagnosis and treatment of hormonal disorders in the early stages of the disease, reduce&#xD;
      the direct financial costs of the diagnostic and treatment process primarily due to the&#xD;
      optimization of hormonal studies and treatment of the revealed disorders, as well as will&#xD;
      prevent the progression of CKD and the severity of the condition of this category of patients&#xD;
      due to the development of hormonal dysfunctions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Assessment of prevalence, clinical manifestations and pathological significance in a&#xD;
           cohort of patients with CKD:&#xD;
&#xD;
             -  hyperprolactinemia, hormonal disorders of a pituitary -gonad axis ;&#xD;
&#xD;
             -  disorders of renin-angiotensin-aldosterone system;&#xD;
&#xD;
             -  pathology of the thyroid and parathyroid glands.&#xD;
&#xD;
        2. Analysis of CKD impact on the development of structural changes in the thyroid gland and&#xD;
           parathyroid glands according to the results of ultrasound examination.&#xD;
&#xD;
        3. Assessment of relationship of hormonal dysfunctions in patients with CKD and&#xD;
           adipocytokines, markers of renal impairment.&#xD;
&#xD;
        4. To study the effect of renal replacement therapy on thyroid hormones clearance .&#xD;
&#xD;
        5. Investigate hormonal status in patients with CKD after kidney transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</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>Hormanal changes in patients with CKD</measure>
    <time_frame>Baseline</time_frame>
    <description>Deviations from reference interval ranges of prolactin, thyroid hormones, PTH and vitamin D and its associations with renal impairment markers</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Hyperprolactinemia</condition>
  <condition>Thyroid Dysfunction</condition>
  <condition>Bone Diseases, Metabolic</condition>
  <condition>Chronic Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Ultrasound examination of the thyroid gland and parathyroid glands, osteodensitometry (DXA), biochemical analysis, general blood count, neutrophil- gelatinase assosiated lipocalin-2 (NGAL), adiponectin, urine albumin / creatinine ratio, hormonal tests (TSH, free T4 and T3, total T4 and T3, Tg, antibodies to thyroid peroxidase (Ab-TPO), Ab--R-TSH, Ab-Tg, parathyroid hormone (PTH), vitamin D, osteocalcin, b-cross-laps, prolactin)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CKD 1-2</arm_group_label>
    <description>Ultrasound examination of the thyroid gland and parathyroid glands, osteodensitometry (DXA), biochemical analysis, general blood count, NGAL, adiponectin, urine albumin / creatinine ratio, hormonal tests (TSH, free T4 and T3, total T4 and T3, Tg, Ab-TPO, Ab--R-TSH, Ab-Tg, PTH, vitamin D, osteocalcin, b-cross-laps, prolactin)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CKD 3-5</arm_group_label>
    <description>Ultrasound examination of the thyroid gland and parathyroid glands, osteodensitometry (DXA), biochemical analysis, general blood count, NGAL, adiponectin, urine albumin / creatinine ratio, hormonal tests (TSH, free T4 and T3, total T4 and T3, Tg, Ab-TPO, Ab--R-TSH, Ab-Tg, PTH, vitamin D, osteocalcin, b-cross-laps,prolactin)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound, DXA, hormonal tests</intervention_name>
    <description>Diagnostic tests in selected groups with investigation of revealed hormonal disorders</description>
    <arm_group_label>CKD 1-2</arm_group_label>
    <arm_group_label>CKD 3-5</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of nephrology departments in Minsk City hospitals and endocrinology department of&#xD;
        Minsk Endocrinology Dispensary from which 2 groups will be selected , healthy volunteers of&#xD;
        Minsk as control group&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients at CKD 1-5, including renal replacement therapy and renal transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with impaired thyroid function before the onset of CKD;&#xD;
&#xD;
          -  pregnant women;&#xD;
&#xD;
          -  patients with acute diseases;&#xD;
&#xD;
          -  patients in the acute phase of comorbid chronic diseases;&#xD;
&#xD;
          -  patients in the acute period of myocardial infarction, after acute cerebrovascular&#xD;
             accident;&#xD;
&#xD;
          -  patients with mental illness;&#xD;
&#xD;
          -  patients undergoing treatment for various cancer types.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tatiana Mokhort, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Head of Endocrinology Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Belarusian State Medical University Endocrinology Department</name>
      <address>
        <city>Minsk</city>
        <zip>220040</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belarus</country>
  </location_countries>
  <link>
    <url>https://doi.org/10.1093/ndt/gfaa142.P1043</url>
    <description>preliminary data</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Belarusian State Medical University</investigator_affiliation>
    <investigator_full_name>Tatiana Mokhort</investigator_full_name>
    <investigator_title>Professor, MD, Head of Endocrinology Department</investigator_title>
  </responsible_party>
  <keyword>hormonal alterations, RRT, CKD, kidney transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Diseases</mesh_term>
    <mesh_term>Bone Diseases, Metabolic</mesh_term>
    <mesh_term>Hyperprolactinemia</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04439747
org study id: 20180438
nct id: NCT04439747
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Methods of diagnostic and treatment of hormonal disorders in patients with chronic kidney
      disease (CKD) will be developed and implemented in real clinical practice. As a result of the
      project, new scientific data will be obtained on the relationship of hyperprolactinemia and
      impaired functioning of the pituitary-gonadal axis, changes in functioning of the
      renin-angiotensin-aldosterone system will be revealed, and the characteristics of the thyroid
      and parathyroid status in patients with CKD will be determined, including receiving renal
      replacement therapy (RRT) and after kidney transplantation, which will improve the efficiency
      of diagnosis and treatment of hormonal disorders in the early stages of the disease, reduce
      the direct financial costs of the diagnostic and treatment process primarily due to the
      optimization of hormonal studies and treatment of the revealed disorders, as well as will
      prevent the progression of CKD and the severity of the condition of this category of patients
      due to the development of hormonal dysfunctions.
1. Assessment of prevalence, clinical manifestations and pathological significance in a
           cohort of patients with CKD:

             -  hyperprolactinemia, hormonal disorders of a pituitary -gonad axis ;

             -  disorders of renin-angiotensin-aldosterone system;

             -  pathology of the thyroid and parathyroid glands.

        2. Analysis of CKD impact on the development of structural changes in the thyroid gland and
           parathyroid glands according to the results of ultrasound examination.

        3. Assessment of relationship of hormonal dysfunctions in patients with CKD and
           adipocytokines, markers of renal impairment.

        4. To study the effect of renal replacement therapy on thyroid hormones clearance .

        5. Investigate hormonal status in patients with CKD after kidney transplantation.
observational model: Cohort
time perspective: Retrospective
measure: Hormanal changes in patients with CKD
time frame: Baseline
description: Deviations from reference interval ranges of prolactin, thyroid hormones, PTH and vitamin D and its associations with renal impairment markers
arm group label: Control
description: Ultrasound examination of the thyroid gland and parathyroid glands, osteodensitometry (DXA), biochemical analysis, general blood count, neutrophil- gelatinase assosiated lipocalin-2 (NGAL), adiponectin, urine albumin / creatinine ratio, hormonal tests (TSH, free T4 and T3, total T4 and T3, Tg, antibodies to thyroid peroxidase (Ab-TPO), Ab--R-TSH, Ab-Tg, parathyroid hormone (PTH), vitamin D, osteocalcin, b-cross-laps, prolactin)
arm group label: CKD 1-2
description: Ultrasound examination of the thyroid gland and parathyroid glands, osteodensitometry (DXA), biochemical analysis, general blood count, NGAL, adiponectin, urine albumin / creatinine ratio, hormonal tests (TSH, free T4 and T3, total T4 and T3, Tg, Ab-TPO, Ab--R-TSH, Ab-Tg, PTH, vitamin D, osteocalcin, b-cross-laps, prolactin)
arm group label: CKD 3-5
description: Ultrasound examination of the thyroid gland and parathyroid glands, osteodensitometry (DXA), biochemical analysis, general blood count, NGAL, adiponectin, urine albumin / creatinine ratio, hormonal tests (TSH, free T4 and T3, total T4 and T3, Tg, Ab-TPO, Ab--R-TSH, Ab-Tg, PTH, vitamin D, osteocalcin, b-cross-laps,prolactin)
intervention type: Other
intervention name: Ultrasound, DXA, hormonal tests
description: Diagnostic tests in selected groups with investigation of revealed hormonal disorders
arm group label: CKD 1-2
arm group label: CKD 3-5
arm group label: Control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tatiana Mokhort, Prof
role: Study Chair
affiliation: Head of Endocrinology Department
facility: 
country: Belarus
url: https://doi.org/10.1093/ndt/gfaa142.P1043
description: preliminary data
responsible party type: Principal Investigator
investigator affiliation: Belarusian State Medical University
investigator full name: Tatiana Mokhort
investigator title: Professor, MD, Head of Endocrinology Department
mesh term: Bone Diseases
mesh term: Bone Diseases, Metabolic
mesh term: Hyperprolactinemia
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Metabolic Diseases
sharing ipd: No