MedTrace Logo

ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation

NCT01972035 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2022-04-12

Study results available
· View outcomes & findings →

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.

Conditions

  • Transplantation Infection
  • Epstein-Barr Virus Infections
  • Cytomegalovirus Infections

Interventions

DRUG

Valacyclovir

Experimental Arm

DRUG

Valganciclovir

Standard of care

Sponsors & Collaborators

Principal Investigators

  • Hank Balfour, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-01
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01972035 on ClinicalTrials.gov