<?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>IRCT20180222038824N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-05</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the Effectiveness and Safety of PDpoetin and cinapoetin in the Remodeling of Anemia in Children with Chronic Renal Failure</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness and safety between Alpha chain Erythropoietin  and Beta chain Erythropoietin produced by Iran in the Remodeling of Anemia in Children with Chronic kidney disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29868</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: efficacy and side effects of these two medication made by Iran has not been compared in children, Randomization description: The patients  Randomization  is Simple and Unit of randomization is individual and according to  table of random number the patients are divided to two groups: 
1) Alpha chain Epoietin produced by Pooyesh darou
2)  Betha chain Epoietin produced by Cinnagen 
In these two groups, the drugs are prescribed based on  KDIGO36 guideline to maintaine hemoglobin range between 11-12 g/dl.
 
In this study concealment was not carried out.</study_design>
      <phase>3</phase>
      <hc_freetext>alpha and Betha erythropoietin, Anemia in CKD.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:The patient with CKD and anemia in children Up to  18 years old, Number: 20 patients, drug: alpha chain Epoietin, Dosage: 100 unit/kg, interval: 1-3 dose per week, duration: 3 months,The route Presciption: SQ, Company: pooyesh darou. Intervention 2: Intervention group 2: Intervention group 1:The patient with CKD and anemia in children Up to  18 years old, Number: 20 patients, drug: Betha chain Epoietin, Dosage: 100 unit/kg, interval: 1-3 dose per week, duration: 3 months,The route Presciption: SQ, Company: CinnaGen.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is there is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Fathi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Modares highway, dastgerdi St, Aliasghar children hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19198167618</zip>
        <telephone>+98 21 2304 6253</telephone>
        <email>dr.fathi51@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nakysa Hooman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>N197, Ali-asghar children hospital, vahid dasgerdi st</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 21 2304 6579</telephone>
        <email>hooman.n@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2></country2>
    </countries>
    <criteria>
      <inclusion_criteria>Parent consent for Research, Children With under 18 years old, children with hemoglobin less than 11 gr/dl,  Renal failure with Grade 3-5 ,if that treatment with  iron and folic acid and vitamin B12  have not modify the anemia,</inclusion_criteria>
      <agemin>3 months</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No consent of parents
Secondary anemia due to causes other than CKD
advanced liver disease
Uncontrolled hyperparathyroidism
Heart failure (New York Heart Association (NYHA) class III and IV)
Discoagulopathy
Thrombocytopenia
leukopenia
Acute or chronic bleeding during the last two month ago
Systemic or inflammatory infection
Major surgery during the last 6 months ago  (except surgery for vessels access )
Immune suppressive treatment
History of malignancy
severe drug hypersensitivity
Every reception of blood during the last 3 months ago
Every primary blood disorder (Myelodysplasia syndrome, Myeloma, Sickle cell anemia, Malignancy, Multiple Myeloma)
Documented resistance to  rHuEPO</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 3 (moderate)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1:The patient with CKD and anemia in children Up to  18 years old, Number: 20 patients, drug: alpha chain Epoietin, Dosage: 100 unit/kg, interval: 1-3 dose per week, duration: 3 months,The route Presciption: SQ, Company: pooyesh darou</i_keyword>
      <i_keyword>Intervention group 2: Intervention group 1:The patient with CKD and anemia in children Up to  18 years old, Number: 20 patients, drug: Betha chain Epoietin, Dosage: 100 unit/kg, interval: 1-3 dose per week, duration: 3 months,The route Presciption: SQ, Company: CinnaGen</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The improve of hemoglobin concentration due to erythropoietin therapy. Timepoint: at the start of study and then every one month in a period of 3 months. Method of measurement: CBC.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Compare the rate of pain, hypertension, thrombosis, other side effects. Timepoint: six months. Method of measurement: pain sacle, measure BP, physical exam.</sec_outcome>
      <sec_outcome>Comparing the dose of drug to correct anemia and maintain HB. Timepoint: six months. Method of measurement: dose calculation per kg/wk.</sec_outcome>
      <sec_outcome>Comparing the Serum electrolytes level between two group. Timepoint: monthly to six months. Method of measurement: K, ca, Ph, PTH level.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-21</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Siences</contact_name>
        <contact_address>Modares highway, Vahid dastgerdy st, Aliasghar Children Hospital Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
