Long Term Use of Valganciclovir for Prophylaxis of CMV Disease in Kidney and Pancreas Transplant Patients
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|ClinicalTrials.gov Identifier: NCT00225394|
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : September 23, 2005
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.
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.
|Condition or disease|
|CMV Disease Viral Resistance Rejection Death|
|Study Type :||Observational|
|Enrollment :||100 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Long-Term Valcyte Therapy in Transplant Patients and the Development of Ganciclovir Resistant CMV|
|Study Start Date :||October 2003|
|Study Completion Date :||July 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225394
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Lahey Clinic Transplant|
|Burlington, Massachusetts, United States, 01803|
|UMass Memorial Medical Center|
|Worcester, Massachusetts, United States, 01655|
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Marc E Uknis, MD||UMass Medical School|