Eligibility, any sex, with Transplantation Infection or Epstein-Barr Virus Infections. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Compare Incidence, Duration and Magnitude of CMV and EBV Viremia in Kidney Transplant Recipients Receiving valA vs. valG.Primary· First year post-kidney transplant
In infectious mononucleosis intervention trials, two weeks of valA therapy resulted in a statistically significant reduction in oral EBV shedding, accompanied by a clinical benefit, and valA is currently used for the therapy of severe cases of infectious mononucleosis in the community. ValA has also been shown to reduce the incidence and delay the onset of CMV disease in both CMV seronegative patients (P\<0.001) and CMV seropositive patients (P=0.03). Therefore we hypothesize that the anti-EBV and anti-CMV effects of valA will be equal to or more effective than valG in reducing post-kidney tra
Group
Value
95% CI
ValAcyclovir
16
ValGanciclovir
20
ValAcyclovir
8
ValGanciclovir
4
ValAcyclovir
5
ValGanciclovir
11
ValAcyclovir
2
ValGanciclovir
1
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year following intervention.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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· NA
· completed
NCT05536349 — Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chroni
· Phase 2
· recruiting
NCT05492591 — A Study Exploring Efficacy of Peginterferon in Patients With Herpes Zoster
· Phase 2
· completed
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Other University of Minnesota trials
Trials by the same sponsor.
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Sponsor: as reported to ClinicalTrials.gov by University of Minnesota
Last refreshed: 12 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01972035.