Long Term Use of Valganciclovir for Prophylaxis of CMV Disease in Kidney and Pancreas Transplant … (NCT00225394) | Clinical Trial Compass
CompletedNot Applicable
Long Term Use of Valganciclovir for Prophylaxis of CMV Disease in Kidney and Pancreas Transplant Patients
United States100 participantsStarted 2003-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Patients receiving systemic therapy for acute opportunistic infection at time of enrollment
. Patients receiving investigational drugs
. Patients with malignancies within the last 5 years with the exception of excised basal or squamous cell skin cancers
. Patients with active substance abuse or other condition that would impair compliance
. Patients who are unable to give informed consent
. Any patient with a creatinine clearance \< 40 after delayed graft function and or post-transplant ATN has completely resolved, or the patient is deemed not to have the prospect of any further improvement of creatinine clearance (\>40) as would occur with resolving ATN.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.