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

NCT00225394 | Completed

• 1 other identifier: VAL031
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

CMV Disease; Viral Resistance; Rejection; Death

Keywords

CMV; Kidney Transplant; Pancreas Transplant; Ganciclovir-resistance; Valganciclovir; CMV Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• 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.
• Persistent ANC \< 1,000 for 2 consecutive weeks despite treatment with G-CSF
• Any female patient who plans to become pregnant within one year

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Beth Israel Deaconess Medical Center: collaborator
• Lahey Clinic: collaborator
• Rhode Island Hospital: collaborator

Study Sites (4)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Clinic Transplant

Burlington, Massachusetts, 01803, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Rejection, Psychology; Death

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc E Uknis, MD

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 23, 2005
• Study Start: October 1, 2003
• Study Completion: July 1, 2006
• Last Updated: September 23, 2005

Record last verified: 2005-08

Locations

US (4)