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NCT00294515 · ClinicalTrials.gov registry record · Phase 3
IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 326
- Enrollment target
NCT00294515: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00294515 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 326 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00294515, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 326 participants
- Enrollment target
Study Summary
This study will determine the relative efficacy and safety of up to 100 days Valcyte prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Primary Outcome
Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 12 months post-transplant.
Interventions
- DRUG Valganciclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2006-03-31 |
| Est. Completion | 2009-08-31 |
| Phase | Phase 3 |
What the finished NCT00294515 record still lists
NCT00294515 is an interventional study that assigns participants to a tested intervention. The registered 326 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Valganciclovir is the first listed.
NCT00294515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00294515 about?
NCT00294515 is a clinical study titled "IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients". This study will determine the relative efficacy and safety of up to 100 days Valcyte prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study treatment is 3-12 months and th...
What is the current status of trial NCT00294515?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 326 participants. The study started on 2006-03-31. Estimated completion is 2009-08-31.
What interventions are being tested in trial NCT00294515?
The interventions under investigation include: Valganciclovir (DRUG).
Who is sponsoring clinical trial NCT00294515?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00294515's enrollment target sits among peer trials
326 1075th of 2000 higher than 925 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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