<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/NCT01689272</url>
  </required_header>
  <id_info>
    <org_study_id>0111RK00337</org_study_id>
    <nct_id>NCT01689272</nct_id>
  </id_info>
  <brief_title>Functional Reserve Estimation of Donor Kidney</brief_title>
  <official_title>Improving of Morphological,Clinical Biochemical and Instrumental Functional Reserve Estimation of Donor Kidney</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nazarbayev University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nazarbayev University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study:&#xD;
&#xD;
        -  To estimate the role of morphological, clinical, biochemical and imaging studies at&#xD;
           stages of kidney transplantation (medical therapy, explantation, preservation,&#xD;
           transplantation).&#xD;
&#xD;
        -  To improve the ways of preserving optimal functional parameters of renal transplants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Terminal chronic renal failure (ESRD) as a result of almost any chronic kidney disease&#xD;
      develops due to progressive loss of nephrons. This state is characterized by a gradual&#xD;
      deterioration of the functional abilities of not only the kidneys, but also the whole body.&#xD;
      Currently, ESRD is among the first ten causes of mortality .&#xD;
&#xD;
      Transplantation of donor organs is the only radical treatment for various diseases of the&#xD;
      terminal, for patients with a fatal prognosis.&#xD;
&#xD;
      Kidney transplantation has allowed not only save lives, but also to return to normal life,&#xD;
      tens of thousands of people. Survival of renal transplant recipients is growing.&#xD;
&#xD;
      Despite the progress made in many clinics worldwide in recent years in the field of&#xD;
      transplantation, kidney transplantation, does not settle the problem of reperfusion injury&#xD;
      and the associated post-transplant dysfunction with the absence of clear indicators of&#xD;
      morphological, clinical, biochemical and instrumental methods to assess functional reserve of&#xD;
      organs that remain relevant and meaningful.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Reserve Estimation of Donor Kidney</measure>
    <time_frame>for 12 months</time_frame>
    <description>Graft survival is assessed on the following criteria:&#xD;
The duration of the functioning graft&#xD;
Clinical, laboratory and device functioning graft.&#xD;
Morphological and histological study of the stages of transplantation (for withdrawal, before implantation) and the post-transplant period (with the threat of rejection.) Study of the blood recipient: Laboratory tests of blood recipient: biochemical analysis, the composition of the electrolyte, acid-base status, the level of immunosuppressants. Immunological typing for HLA-system. Cross-typing of donor and recipient, the level of pre-existing limfotsitotoksicheskih antibodies in the recipient.Patients survival.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical and Laboratory,Imaging Parameters</measure>
    <time_frame>From 2 hours to 7 days</time_frame>
    <description>Intraoperational Macroscopic Description of signs of kidney ischemia: turgor, colour, consistency of transplanted kidney, pulse characteristics of renal artery.&#xD;
Signs of graft rejection: increasing of temperature, blood pressure, the levels of waste products (blood creatinine, blood urea).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pre-Operative Patients Health Status: Donor and Recipient</measure>
    <time_frame>For 1 week</time_frame>
    <description>Patient-donor health status.&#xD;
Concomitant somatic pathology of a patient-recipient.&#xD;
Time for Kidney transplantation.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>End-stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Kidney transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Kidney transplantation from alive relative donor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Kidney Transplantation from alive relative donor</intervention_name>
    <description>Donor kidney sampling, preservation, transport and transplantation</description>
    <arm_group_label>Kidney transplantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  recipients-patients with end-stage renal disease;&#xD;
&#xD;
          -  donor healthy people without absolute contraindications to the kidney transplantation;&#xD;
&#xD;
          -  donor and recipients who are both in the genetic and non-genetic related to each&#xD;
             other.&#xD;
&#xD;
          -  obligatory immunological compatibility by HLA-phenotyping provided that the donor and&#xD;
             recipient are not relatives with each other;&#xD;
&#xD;
          -  negative result of cross-match between donors and recipients;&#xD;
&#xD;
          -  presence of pre-existing lymphotoxic antibodies in a recipient less than 50%;&#xD;
&#xD;
          -  absence of standard absolute contraindications in a donor and in a recipient for&#xD;
             surgeric intervention.&#xD;
&#xD;
        Age is 18-60 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with absolute contraindications to surgery: diseases of organs and systems&#xD;
             having a threating risk to the life of donor and recipient during and after surgery;&#xD;
&#xD;
          -  immunological incompatibility between donor and recipient;&#xD;
&#xD;
          -  high level of pre-existing lymphotoxic antibodies in a recipient more than 50%,&#xD;
             uncorrected by Therapy;&#xD;
&#xD;
          -  donor age is under 18 and over 60 years;&#xD;
&#xD;
          -  incapable persons;&#xD;
&#xD;
          -  absence of a notarized consent form to kidney transplantation;&#xD;
&#xD;
          -  presence of the active phase of viral infection with hepatitis B and C;&#xD;
&#xD;
          -  positive results of blood tests for HIV/AIDS, syphilis;&#xD;
&#xD;
          -  patients with severe concomitant pathology of kidneys, (or) heart and (or)liver.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gani M Kuttymuratov, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Advisor to the Board Chairman</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Republican Scientific Center for Emergency Medicine</name>
      <address>
        <city>Astana</city>
        <zip>010000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kazakhstan</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>February 10, 2015</last_update_submitted>
  <last_update_submitted_qc>February 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Kidney transplantation,functional status,survival.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <!-- 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/NCT01689272
org study id: 0111RK00337
nct id: NCT01689272
lead sponsor: 
has dmc: Yes
The purpose of the study:

        -  To estimate the role of morphological, clinical, biochemical and imaging studies at
           stages of kidney transplantation (medical therapy, explantation, preservation,
           transplantation).

        -  To improve the ways of preserving optimal functional parameters of renal transplants.
Terminal chronic renal failure (ESRD) as a result of almost any chronic kidney disease
      develops due to progressive loss of nephrons. This state is characterized by a gradual
      deterioration of the functional abilities of not only the kidneys, but also the whole body.
      Currently, ESRD is among the first ten causes of mortality .

      Transplantation of donor organs is the only radical treatment for various diseases of the
      terminal, for patients with a fatal prognosis.

      Kidney transplantation has allowed not only save lives, but also to return to normal life,
      tens of thousands of people. Survival of renal transplant recipients is growing.

      Despite the progress made in many clinics worldwide in recent years in the field of
      transplantation, kidney transplantation, does not settle the problem of reperfusion injury
      and the associated post-transplant dysfunction with the absence of clear indicators of
      morphological, clinical, biochemical and instrumental methods to assess functional reserve of
      organs that remain relevant and meaningful.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Functional Reserve Estimation of Donor Kidney
time frame: for 12 months
description: Graft survival is assessed on the following criteria:
The duration of the functioning graft
Clinical, laboratory and device functioning graft.
Morphological and histological study of the stages of transplantation (for withdrawal, before implantation) and the post-transplant period (with the threat of rejection.) Study of the blood recipient: Laboratory tests of blood recipient: biochemical analysis, the composition of the electrolyte, acid-base status, the level of immunosuppressants. Immunological typing for HLA-system. Cross-typing of donor and recipient, the level of pre-existing limfotsitotoksicheskih antibodies in the recipient.Patients survival.
measure: Clinical and Laboratory,Imaging Parameters
time frame: From 2 hours to 7 days
description: Intraoperational Macroscopic Description of signs of kidney ischemia: turgor, colour, consistency of transplanted kidney, pulse characteristics of renal artery.
Signs of graft rejection: increasing of temperature, blood pressure, the levels of waste products (blood creatinine, blood urea).
measure: Pre-Operative Patients Health Status: Donor and Recipient
time frame: For 1 week
description: Patient-donor health status.
Concomitant somatic pathology of a patient-recipient.
Time for Kidney transplantation.
arm group label: Kidney transplantation
arm group type: Experimental
description: Kidney transplantation from alive relative donor.
intervention type: Procedure
intervention name: Kidney Transplantation from alive relative donor
description: Donor kidney sampling, preservation, transport and transplantation
arm group label: Kidney transplantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gani M Kuttymuratov, Phd
role: Principal Investigator
affiliation: Advisor to the Board Chairman
facility: 
country: Kazakhstan
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic