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

NCT00225394 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2005-09-23

No results posted yet for this 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

  • CMV Disease
  • Viral Resistance
  • Rejection
  • Death

Sponsors & Collaborators

  • University of Massachusetts, Worcester

    lead OTHER

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • Lahey Clinic

    collaborator OTHER

  • Rhode Island Hospital

    collaborator OTHER

Principal Investigators

  • Marc E Uknis, MD · UMass Medical School

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Completion
2006-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00225394 on ClinicalTrials.gov