<?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>IRCT20250711066450N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-09</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of telmisartan in comparison with valsartan and losartan  in patients with diabetic nephropathy</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of telmisartan in comparison with valsartan and losartan in the amount of albuminuria in patients with diabetic nephropathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>152</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84890</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly allocated to one of four study groups (telmisartan, losartan, valsartan, or control) using block randomization with a 1:1:1:1 allocation ratio. The random allocation sequence will be generated using Random Allocation Software with a block size of four. The unit of randomization is the individual eligible participant.
To ensure allocation concealment, the randomization sequence will be prepared by a person who is not involved in participant recruitment or outcome assessment. The allocation sequence will be kept in sequentially numbered, opaque, sealed envelopes (SNOSE). After confirming eligibility and obtaining written informed consent, the next envelope in sequence will be opened to determine the participant's treatment allocation. The person generating the randomization sequence will have no role in participant enrollment or outcome assessment.</study_design>
      <phase>3</phase>
      <hc_freetext>Diabetic nephropathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Telmisartan tablets 40 mg(Actoveerco Pharmaceutical Company) daily for 3 months. Intervention 2: Intervention group2:  Losartan tablets 25 mg(Actoveerco Pharmaceutical Company) daily for 3 months. Intervention 3: Intervention group3: Valsartan tablets 40 mg (Actoveerco Pharmaceutical Company)daily for 3 months. Intervention 4: Control group: Participants in the control group will not receive any of the study medications (telmisartan, losartan, or valsartan) during the 3-month study period. They will continue their routine standard care, including antidiabetic medications and other usual treatments as prescribed by their treating physician. Blood pressure, serum creatinine, HbA1c, and the urinary albumin-to-creatinine ratio (UACR) will be measured at baseline and at the end of the study and compared with the intervention groups.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data can be shared after the study is completed and individuals are de-identified.

When:
Access period starts 6 months after results are published.

To whom:
Researchers working in academic and scientific institutions

Conditions:
The documents will be usable with reference to the source and the study direction.

Where to obtain:
Email address  
mohammad68.n121@gmail.com 
Mohammadli shahmoradi

How to obtain:
After sending the email to the researcher, she will immediately receive the documentation.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadali Shamoradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 155, Parvin Etesami blvd, Vahidie town</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515844183</zip>
        <telephone>+98 24 3313 0001</telephone>
        <email>Mohammad68.n121@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadali Shahmoradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No155,parvin etesami blvd,vahidieh town</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515844183</zip>
        <telephone>+98 24 3313 0001</telephone>
        <email>Mohammad68.n121@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>History of type 2 diabetes for more than 5 to 10 years
hemoglobin A1c ≤10%
GFR&gt;60
&gt;30first-morning spot UAC&lt;300</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant women
Presence of kidney disease unrelated to diabetes
CHF
CVA
chronic liver disease
prostatic diseases
diabetes type 1
immunodeficiency diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with diabetic nephropathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Telmisartan tablets 40 mg(Actoveerco Pharmaceutical Company) daily for 3 months</i_keyword>
      <i_keyword>Intervention group2:  Losartan tablets 25 mg(Actoveerco Pharmaceutical Company) daily for 3 months</i_keyword>
      <i_keyword>Intervention group3: Valsartan tablets 40 mg (Actoveerco Pharmaceutical Company)daily for 3 months</i_keyword>
      <i_keyword>Control group: Participants in the control group will not receive any of the study medications (telmisartan, losartan, or valsartan) during the 3-month study period. They will continue their routine standard care, including antidiabetic medications and other usual treatments as prescribed by their treating physician. Blood pressure, serum creatinine, HbA1c, and the urinary albumin-to-creatinine ratio (UACR) will be measured at baseline and at the end of the study and compared with the intervention groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Albuminuria rate in patients with diabetic nephropathy. Timepoint: Before the start of the intervention and at the end of the third month after the intervention. Method of measurement: urine albumin.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serume Creatinine. Timepoint: Before the intervention and at the end of the third month of the intervention. Method of measurement: serume Creatinine.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-06-30</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Zanjan University of Medival SciEnces, Jomhouri street, Azadi square, Etemadieh town Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
