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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Treatments: Ganciclovir; Ganciclovir triphosphate; Valganciclovir

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