<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/NCT02973464</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AF2016LSK-25</org_study_id>
    <nct_id>NCT02973464</nct_id>
  </id_info>
  <brief_title>The Strategy in the Prevention of Renal Post-transplant Cytomegalovirus Infection Among Chinese Population</brief_title>
  <official_title>The Strategy in the Prevention of Renal Post-transplant Cytomegalovirus Infection Among Chinese Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the safety and availability of oral valganciclovir(VGC) at the does of&#xD;
      450mg daily begin within 10 days after renal transplantation, and till to Day 100&#xD;
      posttransplant. Compare to the guidelines for effective antiviral prophylaxis, the&#xD;
      investigators divide these patients into three groups in random. One third will oral VGC&#xD;
      450mg daily as mentioned above; one third will oral VGC 900mg daily; and the other one third&#xD;
      will intravenous GCV 5mg/kg daily within the first 14 days posttransplant, and continue to&#xD;
      oral GCV 1g 3 times daily till to Day 100 posttransplant; with does adjusted per renal&#xD;
      function for all agents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Human Cytomegalovirus(CMV), a kind of β-hepersvirus, which is a common opportunistic&#xD;
      pathogen. The ubiquity of CMV infection in human beings had been verified; and the CMV-IgG&#xD;
      seropositive rate is 97% among healthy population, most of them are at the state of latent&#xD;
      infection. When immunosuppressed, such as for renal transplant recipients, the incidence of&#xD;
      CMV infection and disease increase obviously. The posttransplant CMV infection would induce&#xD;
      allgraft rejection, impact on allgraft and recipients survival, as well as contribute to the&#xD;
      serious complications.Many studies show that giving effective antivirus drugs after&#xD;
      transplantation is benifit to recipients.&#xD;
&#xD;
      Nowadays,the strategy of intravenous GCV GCV 5mg/kg daily or oral GCV 1g 3 times daily, which&#xD;
      is the recommended treatment for CMV disease posttransplantation.Resent date show that VGC is&#xD;
      an oral prodrug of GCV. When VGC is absorbed in the intestinal wall and liver, it is rapidly&#xD;
      metabolized to ganciclovir. As a contemporary study, IV GCV 5mg/kg/day will approach to a&#xD;
      similar area under the curve to VGC 900mg daily. The bioavailability of ganciglovir from&#xD;
      valganciclovir is 10 times of GCV by oral. For recipients, oral therapy is more safety and&#xD;
      convinient, so that it will reduce frequent hospitalizations. As many researches, it is&#xD;
      indicated that oral VGC 450mg daily can also reduce the adverse events resulting from&#xD;
      posttransplant CMV infection, there is no significantly statistic differences when compared&#xD;
      with oral VGC 900mg daily. Simultaneously, lower dose could decrease the risk of leukopenia&#xD;
      and ease the burden for recipients.&#xD;
&#xD;
      This study is a single-center, prospective, observational, corhort study. According to the&#xD;
      inclusion and exclusion criteria, the investigators will recruit 450 patients. And every one&#xD;
      will be followed up for at least 12 months unless death or graft loss, the specific duration&#xD;
      is at baseline, weekly within the first 3 months posttransplantation, month 4, month 5, month&#xD;
      6, month 9, and month 12. Recipients will be followed for CMV-DNA, CMV-pp65, CMV antigenemia,&#xD;
      blood routine test, urinalysis, liver function, renal fuction and the chest X-ray films.&#xD;
      Inverstigators should collect the date of recipient as below: general conditions, such as&#xD;
      age, sex, weight and so on; primary reason for transplant; donor/recipient CMV serostatus;&#xD;
      biopsy-prove acute rejection; opportunistic infections; NODAT; etc. And Chi-square or&#xD;
      Fisher's exact test will be used as appropriate to compare categorical variables, and it is&#xD;
      considered as statistically significant when the 2-sided P-value&lt;0.05. Definitively,&#xD;
      conclusion will be come out to verify the safety and availability of our protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of CMV infection and disease</measure>
    <time_frame>within the first 1 year after renal transplant</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of CMV infection and disease</measure>
    <time_frame>within the first 3 and 6 months after renal transplant respectively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GCV-resistant CMV infection</measure>
    <time_frame>within the first 1 year after renal transplant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean estimated renal function, allograft survival and patient survival</measure>
    <time_frame>within the first 1 year after renal transplant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of acute rejection</measure>
    <time_frame>within the first 1 year after renal transplant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>other opportunistic infections</measure>
    <time_frame>within the first 1 year after renal transplant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events, such as NODAT</measure>
    <time_frame>within the first 1 year after renal transplant</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Renal Transplant Recipients</condition>
  <arm_group>
    <arm_group_label>Valganciclovir 900mg a day</arm_group_label>
    <description>Valganciclovir 900mg tablet by mouth begin within 10 days after renal transplant，once a day till to Day 100 posttransplant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Valganciclovir 450mg a day</arm_group_label>
    <description>Valgancigclovir 450 mg tablet by mouth begin within 10 days after renal transplant，once a day till to Day 100 posttransplant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ganciclovir</arm_group_label>
    <description>Ganciclovir 5mg/kg fluids by intravenous after renal transplant，once a day for the first 14 days；and than sequential Ganciclovir 1g tablet by mouth，third a day till to Day 100 posttransplant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Valganciclovir</intervention_name>
    <description>Oral at a dose of 450mg or 900mg per day begin within 10 days till to Day 100 posttransplant</description>
    <arm_group_label>Valganciclovir 450mg a day</arm_group_label>
    <arm_group_label>Valganciclovir 900mg a day</arm_group_label>
    <other_name>Valcyte</other_name>
    <other_name>Valin ganciclovir</other_name>
    <other_name>VGC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ganciclovir</intervention_name>
    <description>intravenous GCV 5mg/kg/d after renal transplantation for the first 14 days, and then oral GCV 1g 3 times daily till to Day 100 posttransplant.</description>
    <arm_group_label>Ganciclovir</arm_group_label>
    <other_name>Cymevene</other_name>
    <other_name>GCV</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Renal Transplant Recipients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1.65 years old&gt;=Age&gt;=18 years old, male or female&#xD;
&#xD;
          -  2.Renal transplantation first time&#xD;
&#xD;
          -  3.CMV serology donor-positive(D+) or recipient-positive(R+) renal transplant&#xD;
             recipients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.Those who are allergic or resistant to Acyclovir, Valaciclovir, Ganciclovir,&#xD;
             Valganciclovir&#xD;
&#xD;
          -  2.HIV, hepatitis B or hepatitis C patients&#xD;
&#xD;
          -  3.Not in pregnancy or lactation, pregnancy test was negative, and promise not to be&#xD;
             pregnancy during treatment&#xD;
&#xD;
          -  4.Male with a pregnant partner; or lactation&#xD;
&#xD;
          -  5.Suspected CMV disease at enrolment&#xD;
&#xD;
          -  6.Use of anti-CMV therapy within 30 days prior to study&#xD;
&#xD;
          -  7.Multiple organ transplantation&#xD;
&#xD;
          -  8.Uncontrolled diarrhea or evidence of malabsorption&#xD;
&#xD;
          -  9.Liver function tests&gt;3 times the upper level of normal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaoming D Ding, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fan L Liu</last_name>
    <phone>8613201580779</phone>
    <email>liuf10@sina.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiaoming D Ding, PhD</last_name>
    <phone>8602985323749</phone>
    <email>xmding@mail.xju.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>the First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoming D Ding, PhD</last_name>
      <email>xmding@mail.xju.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Tomasec P, Braud VM, Rickards C, Powell MB, McSharry BP, Gadola S, Cerundolo V, Borysiewicz LK, McMichael AJ, Wilkinson GW. Surface expression of HLA-E, an inhibitor of natural killer cells, enhanced by human cytomegalovirus gpUL40. Science. 2000 Feb 11;287(5455):1031. doi: 10.1126/science.287.5455.1031.</citation>
    <PMID>10669413</PMID>
  </reference>
  <reference>
    <citation>Retiere C, Prod'homme V, Imbert-Marcille BM, Bonneville M, Vie H, Hallet MM. Generation of cytomegalovirus-specific human T-lymphocyte clones by using autologous B-lymphoblastoid cells with stable expression of pp65 or IE1 proteins: a tool to study the fine specificity of the antiviral response. J Virol. 2000 May;74(9):3948-52. doi: 10.1128/jvi.74.9.3948-3952.2000.</citation>
    <PMID>10756006</PMID>
  </reference>
  <reference>
    <citation>Zheng Q, Tao R, Gao H, Xu J, Shang S, Zhao N. HCMV-encoded UL128 enhances TNF-alpha and IL-6 expression and promotes PBMC proliferation through the MAPK/ERK pathway in vitro. Viral Immunol. 2012 Apr;25(2):98-105. doi: 10.1089/vim.2011.0064.</citation>
    <PMID>22486303</PMID>
  </reference>
  <reference>
    <citation>Rubin RH. Infectious disease complications of renal transplantation. Kidney Int. 1993 Jul;44(1):221-36. doi: 10.1038/ki.1993.234. No abstract available.</citation>
    <PMID>8394951</PMID>
  </reference>
  <reference>
    <citation>Schmaldienst S, Horl WH. Bacterial infections after renal transplantation. Nephron. 1997;75(2):140-53. doi: 10.1159/000189523. No abstract available.</citation>
    <PMID>9041533</PMID>
  </reference>
  <reference>
    <citation>Streblow DN, Orloff SL, Nelson JA. Acceleration of allograft failure by cytomegalovirus. Curr Opin Immunol. 2007 Oct;19(5):577-82. doi: 10.1016/j.coi.2007.07.012. Epub 2007 Aug 22.</citation>
    <PMID>17716883</PMID>
  </reference>
  <reference>
    <citation>Szczepura A, Westmoreland D, Vinogradova Y, Fox J, Clark M. Evaluation of molecular techniques in prediction and diagnosis of cytomegalovirus disease in immunocompromised patients. Health Technol Assess. 2006 Apr;10(10):1-176. doi: 10.3310/hta10100.</citation>
    <PMID>16595079</PMID>
  </reference>
  <reference>
    <citation>Bendiksen S, Van Ghelue M, Rekvig OP, Gutteberg T, Haga HJ, Moens U. A longitudinal study of human cytomegalovirus serology and viruria fails to detect active viral infection in 20 systemic lupus erythematosus patients. Lupus. 2000;9(2):120-6. doi: 10.1191/096120300678828118.</citation>
    <PMID>10787009</PMID>
  </reference>
  <reference>
    <citation>Zhou L, Fan J, Zheng SS, Ma WH. Prevalence of human cytomegalovirus UL97 D605E mutation in transplant recipients in China. Transplant Proc. 2006 Nov;38(9):2926-8. doi: 10.1016/j.transproceed.2006.08.161.</citation>
    <PMID>17112867</PMID>
  </reference>
  <reference>
    <citation>Dong B, Wang Y, Wang G, Wang W, Zhou H, Fu Y. A retrospective study of cytomegalovirus pneumonia in renal transplant patients. Exp Ther Med. 2014 May;7(5):1111-1115. doi: 10.3892/etm.2014.1577. Epub 2014 Feb 24.</citation>
    <PMID>24940395</PMID>
  </reference>
  <reference>
    <citation>Meije Y, Fortun J, Len O, Aguado JM, Moreno A, Cisneros JM, Gurgui M, Carratala J, Munoz P, Montejo M, Blanes M, Bou G, Perez JL, Torre-Cisneros J, Ramos A, Pahissa A, Gavalda J; Spanish Network for Research on Infection in Transplantation (RESITRA) and the Spanish Network for Research on Infectious Diseases (REIPI). Prevention strategies for cytomegalovirus disease and long-term outcomes in the high-risk transplant patient (D+/R-): experience from the RESITRA-REIPI cohort. Transpl Infect Dis. 2014 Jun;16(3):387-96. doi: 10.1111/tid.12226. Epub 2014 May 8.</citation>
    <PMID>24807640</PMID>
  </reference>
  <reference>
    <citation>Fernandez-Ruiz M, Arias M, Campistol JM, Navarro D, Gomez-Huertas E, Gomez-Marquez G, Diaz JM, Hernandez D, Bernal-Blanco G, Cofan F, Jimeno L, Franco-Esteve A, Gonzalez E, Moreso FJ, Gomez-Alamillo C, Mendiluce A, Luna-Huerta E, Aguado JM; OPERA Study Group. Cytomegalovirus prevention strategies in seropositive kidney transplant recipients: an insight into current clinical practice. Transpl Int. 2015 Sep;28(9):1042-54. doi: 10.1111/tri.12586. Epub 2015 Apr 23.</citation>
    <PMID>25864986</PMID>
  </reference>
  <reference>
    <citation>Khoury JA, Storch GA, Bohl DL, Schuessler RM, Torrence SM, Lockwood M, Gaudreault-Keener M, Koch MJ, Miller BW, Hardinger KL, Schnitzler MA, Brennan DC. Prophylactic versus preemptive oral valganciclovir for the management of cytomegalovirus infection in adult renal transplant recipients. Am J Transplant. 2006 Sep;6(9):2134-43. doi: 10.1111/j.1600-6143.2006.01413.x. Epub 2006 Jun 19.</citation>
    <PMID>16780548</PMID>
  </reference>
  <results_reference>
    <citation>Asberg A, Humar A, Rollag H, Jardine AG, Mouas H, Pescovitz MD, Sgarabotto D, Tuncer M, Noronha IL, Hartmann A; VICTOR Study Group. Oral valganciclovir is noninferior to intravenous ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant. 2007 Sep;7(9):2106-13. doi: 10.1111/j.1600-6143.2007.01910.x. Epub 2007 Jul 19.</citation>
    <PMID>17640310</PMID>
  </results_reference>
  <results_reference>
    <citation>Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.</citation>
    <PMID>20353469</PMID>
  </results_reference>
  <results_reference>
    <citation>Tu PT, Shu KH, Cheng CH, Chen CH, Yu TM, Chuang YW, Huang ST, Tsai SF, Cheng CY, Wu MJ. Universal valganciclovir prophylaxis significantly reduces episodes of first-year cytomegalovirus disease and biopsy-proven acute rejection in kidney transplant recipients. Transplant Proc. 2014;46(2):574-7. doi: 10.1016/j.transproceed.2013.11.115.</citation>
    <PMID>24656016</PMID>
  </results_reference>
  <results_reference>
    <citation>Stevens DR, Sawinski D, Blumberg E, Galanakis N, Bloom RD, Trofe-Clark J. Increased risk of breakthrough infection among cytomegalovirus donor-positive/recipient-negative kidney transplant recipients receiving lower-dose valganciclovir prophylaxis. Transpl Infect Dis. 2015 Apr;17(2):163-73. doi: 10.1111/tid.12349. Epub 2015 Feb 6.</citation>
    <PMID>25661673</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital Xi'an Jiaotong University</investigator_affiliation>
    <investigator_full_name>Ding Xiaoming</investigator_full_name>
    <investigator_title>Director of renel transplant departmet</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cytomegalovirus Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Valganciclovir</mesh_term>
    <mesh_term>Ganciclovir</mesh_term>
    <mesh_term>Ganciclovir triphosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02973464
org study id: XJTU1AF2016LSK-25
nct id: NCT02973464
lead sponsor: 
has dmc: Yes
This study evaluates the safety and availability of oral valganciclovir(VGC) at the does of
      450mg daily begin within 10 days after renal transplantation, and till to Day 100
      posttransplant. Compare to the guidelines for effective antiviral prophylaxis, the
      investigators divide these patients into three groups in random. One third will oral VGC
      450mg daily as mentioned above; one third will oral VGC 900mg daily; and the other one third
      will intravenous GCV 5mg/kg daily within the first 14 days posttransplant, and continue to
      oral GCV 1g 3 times daily till to Day 100 posttransplant; with does adjusted per renal
      function for all agents.
Human Cytomegalovirus(CMV), a kind of β-hepersvirus, which is a common opportunistic
      pathogen. The ubiquity of CMV infection in human beings had been verified; and the CMV-IgG
      seropositive rate is 97% among healthy population, most of them are at the state of latent
      infection. When immunosuppressed, such as for renal transplant recipients, the incidence of
      CMV infection and disease increase obviously. The posttransplant CMV infection would induce
      allgraft rejection, impact on allgraft and recipients survival, as well as contribute to the
      serious complications.Many studies show that giving effective antivirus drugs after
      transplantation is benifit to recipients.

      Nowadays,the strategy of intravenous GCV GCV 5mg/kg daily or oral GCV 1g 3 times daily, which
      is the recommended treatment for CMV disease posttransplantation.Resent date show that VGC is
      an oral prodrug of GCV. When VGC is absorbed in the intestinal wall and liver, it is rapidly
      metabolized to ganciclovir. As a contemporary study, IV GCV 5mg/kg/day will approach to a
      similar area under the curve to VGC 900mg daily. The bioavailability of ganciglovir from
      valganciclovir is 10 times of GCV by oral. For recipients, oral therapy is more safety and
      convinient, so that it will reduce frequent hospitalizations. As many researches, it is
      indicated that oral VGC 450mg daily can also reduce the adverse events resulting from
      posttransplant CMV infection, there is no significantly statistic differences when compared
      with oral VGC 900mg daily. Simultaneously, lower dose could decrease the risk of leukopenia
      and ease the burden for recipients.

      This study is a single-center, prospective, observational, corhort study. According to the
      inclusion and exclusion criteria, the investigators will recruit 450 patients. And every one
      will be followed up for at least 12 months unless death or graft loss, the specific duration
      is at baseline, weekly within the first 3 months posttransplantation, month 4, month 5, month
      6, month 9, and month 12. Recipients will be followed for CMV-DNA, CMV-pp65, CMV antigenemia,
      blood routine test, urinalysis, liver function, renal fuction and the chest X-ray films.
      Inverstigators should collect the date of recipient as below: general conditions, such as
      age, sex, weight and so on; primary reason for transplant; donor/recipient CMV serostatus;
      biopsy-prove acute rejection; opportunistic infections; NODAT; etc. And Chi-square or
      Fisher's exact test will be used as appropriate to compare categorical variables, and it is
      considered as statistically significant when the 2-sided P-value<0.05. Definitively,
      conclusion will be come out to verify the safety and availability of our protocol.
observational model: Cohort
time perspective: Prospective
measure: incidence of CMV infection and disease
time frame: within the first 1 year after renal transplant
measure: incidence of CMV infection and disease
time frame: within the first 3 and 6 months after renal transplant respectively
measure: GCV-resistant CMV infection
time frame: within the first 1 year after renal transplant
measure: mean estimated renal function, allograft survival and patient survival
time frame: within the first 1 year after renal transplant
measure: incidence of acute rejection
time frame: within the first 1 year after renal transplant
measure: other opportunistic infections
time frame: within the first 1 year after renal transplant
measure: adverse events, such as NODAT
time frame: within the first 1 year after renal transplant
arm group label: Valganciclovir 900mg a day
description: Valganciclovir 900mg tablet by mouth begin within 10 days after renal transplant，once a day till to Day 100 posttransplant.
arm group label: Valganciclovir 450mg a day
description: Valgancigclovir 450 mg tablet by mouth begin within 10 days after renal transplant，once a day till to Day 100 posttransplant.
arm group label: Ganciclovir
description: Ganciclovir 5mg/kg fluids by intravenous after renal transplant，once a day for the first 14 days；and than sequential Ganciclovir 1g tablet by mouth，third a day till to Day 100 posttransplant.
intervention type: Drug
intervention name: Valganciclovir
description: Oral at a dose of 450mg or 900mg per day begin within 10 days till to Day 100 posttransplant
arm group label: Valganciclovir 450mg a day
arm group label: Valganciclovir 900mg a day
other name: Valcyte
other name: Valin ganciclovir
other name: VGC
intervention type: Drug
intervention name: Ganciclovir
description: intravenous GCV 5mg/kg/d after renal transplantation for the first 14 days, and then oral GCV 1g 3 times daily till to Day 100 posttransplant.
arm group label: Ganciclovir
other name: Cymevene
other name: GCV
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Xiaoming D Ding, PhD
role: Principal Investigator
affiliation: First Affiliated Hospital Xi'an Jiaotong University
last name: Fan L Liu
phone: 8613201580779
email: liuf10@sina.cn
last name: Xiaoming D Ding, PhD
phone: 8602985323749
email: xmding@mail.xju.edu.cn
facility: 
status: Recruiting
contact: 
country: China
citation: Tomasec P, Braud VM, Rickards C, Powell MB, McSharry BP, Gadola S, Cerundolo V, Borysiewicz LK, McMichael AJ, Wilkinson GW. Surface expression of HLA-E, an inhibitor of natural killer cells, enhanced by human cytomegalovirus gpUL40. Science. 2000 Feb 11;287(5455):1031. doi: 10.1126/science.287.5455.1031.
PMID: 10669413
citation: Retiere C, Prod'homme V, Imbert-Marcille BM, Bonneville M, Vie H, Hallet MM. Generation of cytomegalovirus-specific human T-lymphocyte clones by using autologous B-lymphoblastoid cells with stable expression of pp65 or IE1 proteins: a tool to study the fine specificity of the antiviral response. J Virol. 2000 May;74(9):3948-52. doi: 10.1128/jvi.74.9.3948-3952.2000.
PMID: 10756006
citation: Zheng Q, Tao R, Gao H, Xu J, Shang S, Zhao N. HCMV-encoded UL128 enhances TNF-alpha and IL-6 expression and promotes PBMC proliferation through the MAPK/ERK pathway in vitro. Viral Immunol. 2012 Apr;25(2):98-105. doi: 10.1089/vim.2011.0064.
PMID: 22486303
citation: Rubin RH. Infectious disease complications of renal transplantation. Kidney Int. 1993 Jul;44(1):221-36. doi: 10.1038/ki.1993.234. No abstract available.
PMID: 8394951
citation: Schmaldienst S, Horl WH. Bacterial infections after renal transplantation. Nephron. 1997;75(2):140-53. doi: 10.1159/000189523. No abstract available.
PMID: 9041533
citation: Streblow DN, Orloff SL, Nelson JA. Acceleration of allograft failure by cytomegalovirus. Curr Opin Immunol. 2007 Oct;19(5):577-82. doi: 10.1016/j.coi.2007.07.012. Epub 2007 Aug 22.
PMID: 17716883
citation: Szczepura A, Westmoreland D, Vinogradova Y, Fox J, Clark M. Evaluation of molecular techniques in prediction and diagnosis of cytomegalovirus disease in immunocompromised patients. Health Technol Assess. 2006 Apr;10(10):1-176. doi: 10.3310/hta10100.
PMID: 16595079
citation: Bendiksen S, Van Ghelue M, Rekvig OP, Gutteberg T, Haga HJ, Moens U. A longitudinal study of human cytomegalovirus serology and viruria fails to detect active viral infection in 20 systemic lupus erythematosus patients. Lupus. 2000;9(2):120-6. doi: 10.1191/096120300678828118.
PMID: 10787009
citation: Zhou L, Fan J, Zheng SS, Ma WH. Prevalence of human cytomegalovirus UL97 D605E mutation in transplant recipients in China. Transplant Proc. 2006 Nov;38(9):2926-8. doi: 10.1016/j.transproceed.2006.08.161.
PMID: 17112867
citation: Dong B, Wang Y, Wang G, Wang W, Zhou H, Fu Y. A retrospective study of cytomegalovirus pneumonia in renal transplant patients. Exp Ther Med. 2014 May;7(5):1111-1115. doi: 10.3892/etm.2014.1577. Epub 2014 Feb 24.
PMID: 24940395
citation: Meije Y, Fortun J, Len O, Aguado JM, Moreno A, Cisneros JM, Gurgui M, Carratala J, Munoz P, Montejo M, Blanes M, Bou G, Perez JL, Torre-Cisneros J, Ramos A, Pahissa A, Gavalda J; Spanish Network for Research on Infection in Transplantation (RESITRA) and the Spanish Network for Research on Infectious Diseases (REIPI). Prevention strategies for cytomegalovirus disease and long-term outcomes in the high-risk transplant patient (D+/R-): experience from the RESITRA-REIPI cohort. Transpl Infect Dis. 2014 Jun;16(3):387-96. doi: 10.1111/tid.12226. Epub 2014 May 8.
PMID: 24807640
citation: Fernandez-Ruiz M, Arias M, Campistol JM, Navarro D, Gomez-Huertas E, Gomez-Marquez G, Diaz JM, Hernandez D, Bernal-Blanco G, Cofan F, Jimeno L, Franco-Esteve A, Gonzalez E, Moreso FJ, Gomez-Alamillo C, Mendiluce A, Luna-Huerta E, Aguado JM; OPERA Study Group. Cytomegalovirus prevention strategies in seropositive kidney transplant recipients: an insight into current clinical practice. Transpl Int. 2015 Sep;28(9):1042-54. doi: 10.1111/tri.12586. Epub 2015 Apr 23.
PMID: 25864986
citation: Khoury JA, Storch GA, Bohl DL, Schuessler RM, Torrence SM, Lockwood M, Gaudreault-Keener M, Koch MJ, Miller BW, Hardinger KL, Schnitzler MA, Brennan DC. Prophylactic versus preemptive oral valganciclovir for the management of cytomegalovirus infection in adult renal transplant recipients. Am J Transplant. 2006 Sep;6(9):2134-43. doi: 10.1111/j.1600-6143.2006.01413.x. Epub 2006 Jun 19.
PMID: 16780548
citation: Asberg A, Humar A, Rollag H, Jardine AG, Mouas H, Pescovitz MD, Sgarabotto D, Tuncer M, Noronha IL, Hartmann A; VICTOR Study Group. Oral valganciclovir is noninferior to intravenous ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant. 2007 Sep;7(9):2106-13. doi: 10.1111/j.1600-6143.2007.01910.x. Epub 2007 Jul 19.
PMID: 17640310
citation: Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.
PMID: 20353469
citation: Tu PT, Shu KH, Cheng CH, Chen CH, Yu TM, Chuang YW, Huang ST, Tsai SF, Cheng CY, Wu MJ. Universal valganciclovir prophylaxis significantly reduces episodes of first-year cytomegalovirus disease and biopsy-proven acute rejection in kidney transplant recipients. Transplant Proc. 2014;46(2):574-7. doi: 10.1016/j.transproceed.2013.11.115.
PMID: 24656016
citation: Stevens DR, Sawinski D, Blumberg E, Galanakis N, Bloom RD, Trofe-Clark J. Increased risk of breakthrough infection among cytomegalovirus donor-positive/recipient-negative kidney transplant recipients receiving lower-dose valganciclovir prophylaxis. Transpl Infect Dis. 2015 Apr;17(2):163-73. doi: 10.1111/tid.12349. Epub 2015 Feb 6.
PMID: 25661673
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital Xi'an Jiaotong University
investigator full name: Ding Xiaoming
investigator title: Director of renel transplant departmet
mesh term: Cytomegalovirus Infections
mesh term: Valganciclovir
mesh term: Ganciclovir
mesh term: Ganciclovir triphosphate
sharing ipd: No