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NCT01972035 · ClinicalTrials.gov registry record · Phase 2
ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation
A Phase 2 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 137
- Enrollment target
NCT01972035: Completed Phase 2 study, sponsored by University of Minnesota.
NCT01972035 is a Phase 2 study that has completed, run by University of Minnesota. The registered enrollment target is 137 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01972035, a Phase 2 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 137 participants
- Enrollment target
Study 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.
Primary Outcome
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 a
Interventions
- DRUG Valacyclovir
- DRUG Valganciclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2014-08-01 |
| Est. Completion | 2021-02-28 |
| Phase | Phase 2 |
What the finished NCT01972035 record still lists
NCT01972035 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Valacyclovir is the first listed.
NCT01972035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01972035 about?
NCT01972035 is a clinical study titled "ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation". 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 req...
What is the current status of trial NCT01972035?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 137 participants. The study started on 2014-08-01. Estimated completion is 2021-02-28.
What interventions are being tested in trial NCT01972035?
The interventions under investigation include: Valacyclovir (DRUG), Valganciclovir (DRUG).
Who is sponsoring clinical trial NCT01972035?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01972035's enrollment target sits among peer trials
137 527th of 2000 higher than 1,474 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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