ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT01972035
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Valacyclovir — DRUG
    Experimental Arm
  • Valganciclovir — DRUG
    Standard of care

Study Details

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.

Key Dates

Start date
Aug 1, 2014
Status verified
Mar 2022
Primary completion
Feb 28, 2021
Completion
Feb 28, 2021

Study Design

Enrollment
137 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: ValAcyclovir
    Kidney recipients who give informed consent will be randomly assigned to receive ValA or ValG in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.
  • Active Comparator: ValGanciclovir
    Kidney recipients who give informed consent will be randomly assigned to receive ValG or ValA in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.

Primary Outcome Measure

Compare Incidence, Duration and Magnitude of CMV and EBV Viremia in Kidney Transplant Recipients Receiving valA vs. valG. [ Time Frame: First year post-kidney transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MNMinneapolisMinnesota55455-

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By research site
University of MN· Minneapolis, MN

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