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

December 1, 2016 updated by: Ding Xiaoming, First Affiliated Hospital Xi'an Jiaotong University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Renal Transplant Recipients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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
  • VGC
  • Valin ganciclovir
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
  • VGC
  • Valin ganciclovir
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of CMV infection and disease
Time Frame: within the first 1 year after renal transplant
within the first 1 year after renal transplant

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: xiaoming D Ding, PhD, First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimate)

November 25, 2016

Study Record Updates

Last Update Posted (Estimate)

December 2, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2016LSK-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe