Phase 2
Completed N=137
ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation
Transplantation Infection · Epstein-Barr Virus Infections · Cytomegalovirus Infections
Source: ClinicalTrials.gov NCT01972035 ↗
Enrolled (actual)
137
Serious AEs
74.5%
Results posted
Mar 2022
Primary outcomePrimary: Compare Incidence, Duration and Magnitude of CMV and EBV Viremia in Kidney Transplant Recipients Receiving valA vs. valG. — 16; 20; 8; 4 Participants
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.
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 | — |
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.
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. Informational only — not medical advice.