<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220708055414N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-19</date_registration>
      <primary_sponsor>Orchidpharmed</primary_sponsor>
      <public_title>Evaluation Renoprotective Effect SGLT2 inhibitors on Prognosis of Transplant Kidney Patients</public_title>
      <acronym>SGLT2 I</acronym>
      <scientific_title>Evaluation Renoprotective Effect SGLT2 inhibitors on Prognosis of Transplant Kidney Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64754</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly divided into two groups based on whether the last digit of the patient's national code is even or odd, Blinding description: Participant: People who were invited to participate in the study and after full explanations about the design and obtaining informed consent were divided into two intervention and control groups based on whether the national number was even or odd.
Researcher: I, who aim to investigate the renoprotective effects of SGLT2 inhibitors on kidney transplant patients, and I am also responsible for collecting data and preparing the draft, without knowing whether the patient's medication box is a drug or a placebo based on the criteria for entering and exiting the box. Medicines were provided to patients.
Data analyst: one of the statisticians of the center who analyzes the data according to the numbers of the groups and does not know the control and intervention groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Diabetes mellitus type 2. Condition 2: Transplant Kidney.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The group that takes Empagloflozin tablets 10 mg daily for 24 weeks. Intervention 2: Control group:  The group that takes Plasebo(lactose monohydrate) tablets daily for 24 weeks.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati hospital, North Kargar Street, Jalal AlAhmad Highway</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8490 1000</telephone>
        <email>shariatihosp@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fattemeh Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati hospital, North Kargar Street, Jalal AlAhmad Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8490 1000</telephone>
        <email>shariatihosp@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age&gt;18 years old
Stable state of renal function for at least the last three months
Consent to participate in the study
Sustained immunosuppressive therapy for at least three months
Transplantation &gt; one year ago
Diabetic patient according to the criteria of the American Diabetes Association</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Surgery or medical conditions that affect the rate of Absorption,Distribution and Metabolism or Excretion of the drug
More than one transplant
Pregnancy or Breastfeeding
Allergy or Contraindications
Type 1 diabetes
Participation in any clinical study within 3 months before the initial dose
GFR&gt;45
Frequent UTI
History of Alcohol use in the 12 months prior to the initial dose
Donating blood or Removing 400 ml of blood is required 8 weeks before the initial dose</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.2</hc_code>
      <hc_code>Z94.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with kidney complications</hc_keyword>
      <hc_keyword>Kidney transplant status</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The group that takes Empagloflozin tablets 10 mg daily for 24 weeks</i_keyword>
      <i_keyword>Control group:  The group that takes Plasebo(lactose monohydrate) tablets daily for 24 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Function of transplant kidney. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Glomerular filteration rate-Creatinine(lab test).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>FBS. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory  biochemical tests.</sec_outcome>
      <sec_outcome>Hb A1C. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory  biochemical tests.</sec_outcome>
      <sec_outcome>Hemoglobin. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory  biochemical tests.</sec_outcome>
      <sec_outcome>Hematocrite. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory  biochemical tests.</sec_outcome>
      <sec_outcome>Uric acid. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory  biochemical tests.</sec_outcome>
      <sec_outcome>Na. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory  biochemical tests.</sec_outcome>
      <sec_outcome>Potasium. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory  biochemical tests.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Orchidpharmed</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-02</approval_date>
        <contact_name>Ethics committee of Faculty of Medicine, Tehran University of Medical Sciences</contact_name>
        <contact_address>Faculty of Medicine, North Gate of University, Porsina St., Quds St., Elkhebal St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
