Kidney Transplant Clinical Trials

Clinical trials related to Kidney Transplant Procedure

Non-Inferiority Assessment of Valacyclovir Versus Valganciclovir as Prophylaxis Against CMV and EBV Viremia in Kidney Transplant Recipients: A Single-Center Prospective Randomized Pilot Study.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Opportunistic CMV viremia (primary infection or reactivation) is usually managed by taking prophylactic medication for both adult and pediatric kidney transplant patients. Most hospitals prescribe valganciclovir for this purpose but valacyclovir has also been used. The most unfavorable side effect of valganciclovir is bone marrow suppression which can be troublesome for kidney transplant patients who are already immunosuppressed. We aim to assess the non-inferiority of valacyclovir compared with valganciclovir in this study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Healthy Volunteers: f
View:

• Age at least 3 years of age

• Patients who are about to receive or just received kidney transplantation within the past 2 weeks before the date of screening.

• Will be receiving prophylactic antiviral therapy against CMV and/or EBV per discretion of transplant surgeon

• No active CMV or EBV viremia (as defined by detectable viral load PCR) at the time of screening.

• Ability and willingness of the patient (or parent/legal guardian for minors) to provide informed consent and comply with study procedures.

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Hou-Xuan Huang, MD
hxhuang@ntuh.gov.tw
886-2312-3456
Time Frame
Start Date: 2025-11-27
Estimated Completion Date: 2030-12
Participants
Target number of participants: 80
Treatments
Experimental: Experimental Group (Valacyclovir)
Standard adult dose for Valacyclovir will be 1000 mg orally twice daily. For pediatric patients, dosing will be weight-based 20 mg/kg/dose twice daily; maximum dose: 1000 mg/dose. The exact dosage will be adjusted for renal function based on published guidelines.~Patients will continue their assigned prophylactic regimen for at least 6 months.
Active_comparator: Control group (Valganciclovir)
Standard adult dose for Valganciclovir will be 450 mg orally once daily. For pediatric patients, dosing will be weight-based 15 mg/kg/dose once daily; maximum dose: 450 mg/dose. The exact dosage will be adjusted for renal function based on published guidelines.~For pediatric patients who could not swallow pills, Valganciclovir also comes in the form of suspension (prepared by National Taiwan University Hospital in-house pharmacy).~Patients will continue their assigned prophylactic regimen for at least 6 months.
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov