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Trial record 65 of 101 for:    Valcyte

The Strategy in the Prevention of Renal Post-transplant Cytomegalovirus Infection Among Chinese Population

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ClinicalTrials.gov Identifier: NCT02973464
Recruitment Status : Recruiting
First Posted : November 25, 2016
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
Ding Xiaoming, First Affiliated Hospital Xi'an Jiaotong University

Brief Summary:
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.

Condition or disease Intervention/treatment
Renal Transplant Recipients Drug: Valganciclovir Drug: Ganciclovir

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Strategy in the Prevention of Renal Post-transplant Cytomegalovirus Infection Among Chinese Population
Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
Valganciclovir 900mg a day
Valganciclovir 900mg tablet by mouth begin within 10 days after renal transplant,once a day till to Day 100 posttransplant.
Drug: Valganciclovir
Oral at a dose of 450mg or 900mg per day begin within 10 days till to Day 100 posttransplant
Other Names:
  • Valcyte
  • Valin ganciclovir
  • VGC

Valganciclovir 450mg a day
Valgancigclovir 450 mg tablet by mouth begin within 10 days after renal transplant,once a day till to Day 100 posttransplant.
Drug: Valganciclovir
Oral at a dose of 450mg or 900mg per day begin within 10 days till to Day 100 posttransplant
Other Names:
  • Valcyte
  • Valin ganciclovir
  • VGC

Ganciclovir
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.
Drug: Ganciclovir
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.
Other Names:
  • Cymevene
  • GCV




Primary Outcome Measures :
  1. incidence of CMV infection and disease [ Time Frame: within the first 1 year after renal transplant ]

Secondary Outcome Measures :
  1. incidence of CMV infection and disease [ Time Frame: within the first 3 and 6 months after renal transplant respectively ]
  2. GCV-resistant CMV infection [ Time Frame: within the first 1 year after renal transplant ]
  3. mean estimated renal function, allograft survival and patient survival [ Time Frame: within the first 1 year after renal transplant ]
  4. incidence of acute rejection [ Time Frame: within the first 1 year after renal transplant ]
  5. other opportunistic infections [ Time Frame: within the first 1 year after renal transplant ]
  6. adverse events, such as NODAT [ Time Frame: within the first 1 year after renal transplant ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Renal Transplant Recipients
Criteria

Inclusion Criteria:

  • 1.65 years old>=Age>=18 years old, male or female
  • 2.Renal transplantation first time
  • 3.CMV serology donor-positive(D+) or recipient-positive(R+) renal transplant recipients

Exclusion Criteria:

  • 1.Those who are allergic or resistant to Acyclovir, Valaciclovir, Ganciclovir, Valganciclovir
  • 2.HIV, hepatitis B or hepatitis C patients
  • 3.Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnancy during treatment
  • 4.Male with a pregnant partner; or lactation
  • 5.Suspected CMV disease at enrolment
  • 6.Use of anti-CMV therapy within 30 days prior to study
  • 7.Multiple organ transplantation
  • 8.Uncontrolled diarrhea or evidence of malabsorption
  • 9.Liver function tests>3 times the upper level of normal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973464


Contacts
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Contact: Fan L Liu 8613201580779 liuf10@sina.cn
Contact: Xiaoming D Ding, PhD 8602985323749 xmding@mail.xju.edu.cn

Locations
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China, Shaanxi
the First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Xiaoming D Ding, PhD       xmding@mail.xju.edu.cn   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Principal Investigator: Xiaoming D Ding, PhD First Affiliated Hospital Xi'an Jiaotong University

Publications of Results:
Other Publications:

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Responsible Party: Ding Xiaoming, Director of renel transplant departmet, First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02973464     History of Changes
Other Study ID Numbers: XJTU1AF2016LSK-25
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Valganciclovir
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action