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NCT00225394 · ClinicalTrials.gov registry record
Long Term Use of Valganciclovir for Prophylaxis of CMV Disease in Kidney and Pancreas Transplant Patients
A clinical trial of Death and CMV Disease, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- 100
- Enrollment target
- 4
- Study locations
NCT00225394 is a study of Death and CMV Disease that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 100 participants, below the 26,854-participant average among 7 other Death trials with a reported enrollment target (100% lower). The trial reports 4 study locations across 2 states.
The verdict
NCT00225394, a study of Death and CMV Disease, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
- 4
- Study locations
Study Summary
CMV viral disease negatively affects transplant patients. CMV is the most prevalent infection in transplant patients and 3 month drug regimens to prevent the virus have been mostly unsuccessful, usually after the drug has been stopped, the patient develops the viral disease. Extended use of anti-viral drugs may, in fact, may lead to the development of resistant virus. We hypothesize that extended use (12 months) of valganciclovir (Valcyte™)will not only be efficacious but will not be associated with the development of resistant CMV. Sample Size: 100 patients at 3 sites have been enrolled Patient Selection: Adult (\>18 years) recipients of cadaveric or living donor kidneys, pancreas, or combine kidney-pancreas transplants. Immunosuppression: To be determined according to each center's standard protocol (s). Study Drug: Valcyte™ Days 0 - 90: All Patients, 900 mg QD Days 91 - 365: Group 1: 900 mg QD Group 2: 450 mg QD Assessment of Valgancicovir (Valcyte™)Resistant CMV : Serial serum samples (at transplant, 6 weeks, and 3, 6, 9 and 12 months post-transplant) for PCR amplification and DNA sequence analysis from detectable CMV to identify the presence of mutations within the UL97 and UL54 genes. Other Analyses: Additional information will be evaluated relating to the development of CMV disease, development of ganciclovir toxicity, graft rejection or graft loss and patient death. Preliminary information regarding the predictive value of DNA assays for the development of CMV disease will be evaluated.
Conditions Studied
Study Locations (4)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Lahey Clinic Transplant - Burlington
- UMass Memorial Medical Center - Worcester
Rhode Island
- Rhode Island Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2003-10 |
| Est. Completion | 2006-07 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00225394
The ClinicalTrials.gov registry entry for NCT00225394 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 26,854-participant average among 7 other Death trials with a reported enrollment target (100% lower). The listed sponsor is University of Massachusetts, Worcester, which has 240 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Death appearing as the primary indexed condition, and to 0 interventions.
NCT00225394 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Rhode Island.
Frequently Asked Questions
What is clinical trial NCT00225394 about?
NCT00225394 is a clinical study titled "Long Term Use of Valganciclovir for Prophylaxis of CMV Disease in Kidney and Pancreas Transplant Patients". CMV viral disease negatively affects transplant patients. CMV is the most prevalent infection in transplant patients and 3 month drug regimens to prevent the virus have been mostly unsuccessful, usually after the drug has been stopped, the patient develops the viral disease. Extended use of anti-vir...
What is the current status of trial NCT00225394?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2003-10. Estimated completion is 2006-07.
What conditions does trial NCT00225394 study?
This clinical trial studies the following conditions: Death, CMV Disease, Viral Resistance, Rejection.
Who is sponsoring clinical trial NCT00225394?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00225394 being conducted?
This trial has 4 study locations across Massachusetts, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.