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Long Term Use of Valganciclovir for Prophylaxis of CMV Disease in Kidney and Pancreas Transplant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00225394
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : September 23, 2005
Beth Israel Deaconess Medical Center
Lahey Clinic
Rhode Island Hospital
Information provided by:
University of Massachusetts, Worcester

Brief 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.

Condition or disease
CMV Disease Viral Resistance Rejection Death

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Study Type : Observational
Enrollment : 100 participants
Observational Model: Defined Population
Time Perspective: Prospective
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

1) Age greater than 18 years 2) WBC greater than 2000/mm3 with ANC greater than 500/mm3 3) Platelet count greater than 50,000/mm3 4) Hematocrit greater than 24 5) Life expectancy greater than 1 year as determined by investigator 6) Females must have a negative pregnancy test and any sexual partner must also agree to practice a barrier and/or hormonal method of birth control while participating in this study and for 90 days after. Females must agree to have a pregnancy test if a menstrual cycle is missed, and if positive, this must be reported.


Exclusion Criteria:

  1. Patients receiving systemic therapy for acute opportunistic infection at time of enrollment
  2. Patients receiving investigational drugs
  3. Patients with malignancies within the last 5 years with the exception of excised basal or squamous cell skin cancers
  4. Patients with active substance abuse or other condition that would impair compliance
  5. Patients who are unable to give informed consent
  6. 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.
  7. Persistent ANC < 1,000 for 2 consecutive weeks despite treatment with G-CSF
  8. Any female patient who plans to become pregnant within one year

Information from the National Library of Medicine

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 identifier (NCT number): NCT00225394

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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
Sponsors and Collaborators
University of Massachusetts, Worcester
Beth Israel Deaconess Medical Center
Lahey Clinic
Rhode Island Hospital
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Principal Investigator: Marc E Uknis, MD UMass Medical School
Layout table for additonal information Identifier: NCT00225394    
Other Study ID Numbers: VAL031
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: September 23, 2005
Last Verified: August 2005
Keywords provided by University of Massachusetts, Worcester:
Kidney Transplant
Pancreas Transplant
CMV Disease