<?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>IRCT201604253043N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-21</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the starting time of tacrolimus administration in management of kidney transplant recipients</public_title>
      <acronym></acronym>
      <scientific_title>Comparing de novo versus delayed tacrolimus administration on allograft function in kidney transplant recipients: a randomized, open-label, clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3056</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>3</phase>
      <hc_freetext>Kidney transplant.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1:  Tacrolimus will be started from a few hours before transplantation at a dose of 0.08 to 0.1 mg / kg / day in two divided doses ( The target level of 8-10 ng / ml).&#13;
Serum creatinine and urine output will be assessed daily during hospitalization. Serum creatinine witll be assessed monthly after hospital discharge up to month 3 after kidney transplantatioد.&#13;
Tacrolimus whole blood concentrations will be checked twice weekly during hospitalizations and monthly thereafter up to month 3 after transplantation. Intervention 2: Intervention 2:Tacrolimus will be started from the third day after kidney transplantation at a dose of 0.08 to 0.1 mg / kg / day in two divided doses  (The target level of 8-10 ng / ml).&#13;
   Serum creatinine and urine output will be assessed daily during hospitalization. Serum creatinine witll be assessed monthly after hospital discharge up to month 3 after kidney transplantation. &#13;
      Tacrolimus whole blood concentrations will be checked twice weekly during hospitalizations and monthly thereafter up to month 3 after transplantation.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Maryam Ghadimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16Azar St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6695 4709</telephone>
        <email>ghadimimaryam4449@yahoo.com</email>
        <affiliation>Department of Clinical Pharmacy, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.  Simin Dashti-Khavidaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16Azar St.</address>
        <city>Teharn</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6695 4709</telephone>
        <email>dashtis@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: All patients who underwent the first of Deceased donor or Living donor kidney transplantation in Imam Khomeini Hospital Complex, Tehran, Iran ; Age  is ≥ 14 y ; Patients who receive thymoglobulin induction ; Patients who receive  Mycophenolate and Prednisone plus Tacrolimus  as immunosuppressive regimen.&#13;
Exclusion criteria: Patients with unstable cardiac, hepatic, pulmonary functions after kidney transplantation ; Patients who have multiple organ transplantation ; Patients with  known  malignancy.</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z94.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Kidney transplant status</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1:  Tacrolimus will be started from a few hours before transplantation at a dose of 0.08 to 0.1 mg / kg / day in two divided doses ( The target level of 8-10 ng / ml).&#13;
Serum creatinine and urine output will be assessed daily during hospitalization. Serum creatinine witll be assessed monthly after hospital discharge up to month 3 after kidney transplantatioد.&#13;
Tacrolimus whole blood concentrations will be checked twice weekly during hospitalizations and monthly thereafter up to month 3 after transplantation.</i_keyword>
      <i_keyword>Intervention 2:Tacrolimus will be started from the third day after kidney transplantation at a dose of 0.08 to 0.1 mg / kg / day in two divided doses  (The target level of 8-10 ng / ml).&#13;
   Serum creatinine and urine output will be assessed daily during hospitalization. Serum creatinine witll be assessed monthly after hospital discharge up to month 3 after kidney transplantation. &#13;
      Tacrolimus whole blood concentrations will be checked twice weekly during hospitalizations and monthly thereafter up to month 3 after transplantation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Recipient's serum creatinine. Timepoint: Before the transplantation, every 6 hours on the first day of transplant, then daily during hospitalization, then weekly until the end of the first month after transplant, then monthly until the end of the third month after transplat. Method of measurement: Blood samples in laboratories in milligrams / deciliter.</prim_outcome>
      <prim_outcome>Recipient's urine output. Timepoint: Before transplantation and daily during hospitalization. Method of measurement: Graduated container in ml/day.</prim_outcome>
      <prim_outcome>Incidence of DGF. Timepoint: During first  week after transplantation. Method of measurement: Need for dialysis.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Graft survival. Timepoint: First three months after transplantation. Method of measurement: Number of functioning kidney.</sec_outcome>
      <sec_outcome>The incidence of acute rejection. Timepoint: During the first three months after transplantation. Method of measurement: Based on function of transplanted kidney.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-09</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences, 16 Azar St., Enghelab St, Tehran, Iran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
