IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT00294515. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
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Official title
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Efficacy and Safety of up to 100 Days of Valganciclovir Versus up to 200 Days of Valganciclovir for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Kidney Allograft Recipients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00294515
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 326 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2006 (Actual)
- Primary completion
- Aug 31, 2008 (Actual)
- Completion
- Aug 31, 2009 (Actual)
- Last update posted
- Mar 29, 2018
2006 – 2009
United States locations
- U.S. sites
- 23
- U.S. states
- 15
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Uni of Alabama At Birmingham | Birmingham | Alabama | 35294 | — |
| National Institute of Transplantation | Los Angeles | California | 90057 | — |
| UCLA Medical Center | Los Angeles | California | 90095 | — |
| Ucsd Medical Center; Kidney Transplantation | San Diego | California | 92103-8401 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| Uni of California San Francisco; Transplant Services | San Francisco | California | 94143-0116 | — |
| Lifelink Healthcare Inst. | Tampa | Florida | 33606 | — |
| Rush-Presbyterian St. Luke'S Medical Center; Rush Uni Renal Transplant Program | Chicago | Illinois | 60612-3824 | — |
| Indiana Uni Medical Center; Surgery & Microbiology/Immunology | Indianapolis | Indiana | 46202-5124 | — |
| New England Medical Center; Division of Transplant Surgery | Boston | Massachusetts | 02111 | — |
| Uni of Michigan Medical Center | Ann Arbor | Michigan | 48109-0331 | — |
| Uni of Minnesota Medical Center; Dept of Surgery | Minneapolis | Minnesota | 55455 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| St. Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| Robert Wood Johnson Uni Hospital; Anesthesia | New Brunswick | New Jersey | 08901 | — |
| Wake Forest Uni School of Medicine; Section on Infectious Diseases | Winston-Salem | North Carolina | 27157-1082 | — |
| Oregon Health Sciences Uni ; Division of Nephrology | Portland | Oregon | 97201 | — |
| Hahnemann Uni Hospital; Division of Transplant/Dept. of Surgery | Philadelphia | Pennsylvania | 19102-1192 | — |
| Uni of Pennslyvania Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Vanderbilt Uni ; Divison of Nephrology | Nashville | Tennessee | 37232 | — |
| Texas Transplant Inst. | San Antonio | Texas | 78229 | — |
| Uni of Texas Health Science Center At San Antonio; Organ Transplant Program | San Antonio | Texas | 78284 | — |
| Uni of Washington Medical Center; Division of Allergy & Infectious Diseases | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 57 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00294515, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 29, 2018 · Synced Nov 14, 2026
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