CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 137 enrolled
Drug / intervention
Valacyclovir +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01972035
NCT01972035Phase 2Completed
CompareCT.gov

ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation

University of Minnesota·interventional·Posted Oct 30, 2013·Updated Apr 12, 2022

In Brief

A Phase 2 clinical trial evaluating Valacyclovir and Valganciclovir for Transplantation Infection and 2 related conditions. Completed, enrolled 137 participants across 1 site.

Detailed Summary

Our study will compare all kidney transplant recipients receiving valganciclovir vs. valacyclovir for one year following kidney transplant and compare: 1. the incidence, magnitude and duration of CMV and EBV viremia in the first year after transplant. 2. the side effects of the anti-viral drugs requiring dose reduction or cessation In addition, we will test renal tissue obtained from any biopsies post-transplant (surveillance or clinically indicated biopsies) by both polymerase chain reaction (PCR) and fluorescence in situ hybridization to assess for latent CMV and/or EBV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTransplantation Infection, Epstein-Barr Virus Infections, Cytomegalovirus Infections
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 30, 2013
Enrollment StartAug 1, 2014
Primary CompletionFeb 28, 2021
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 12.7 years ago

Interventions

Valacyclovirdrug

Experimental Arm

Valganciclovirdrug

Standard of care