Renal Transplant Recipients Clinical Trial
Official title:
The Strategy in the Prevention of Renal Post-transplant Cytomegalovirus Infection Among Chinese Population
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.
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