Phase 2 N=137 Randomized Prevention

ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation

Transplantation Infection · Epstein-Barr Virus Infections · Cytomegalovirus Infections

Bottom Line

View on ClinicalTrials.gov: NCT01972035 ↗

Enrolled (actual)

137

Serious AEs

74.5%

Results posted

Mar 2022

Primary outcome: Primary: Compare Incidence, Duration and Magnitude of CMV and EBV Viremia in Kidney Transplant Recipients Receiving valA vs. valG. — 16; 20; 8; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Valacyclovir (Drug); Valganciclovir (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: University of Minnesota
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Compare Incidence, Duration and Magnitude of CMV and EBV Viremia in Kidney Transplant Recipients Receiving valA vs. valG.	16; 20; 8; 4; 5; 11	—

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.

Eligibility Criteria

Inclusion Criteria

All consenting kidney transplant recipients.

Exclusion Criteria

Non-consent.
Recipients with allergies to valacyclovir or valganciclovir
Recipients that are unable to independently understand the consent form and do not have a legally authorized representative.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01972035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.